TPLC - Total Product Life Cycle

• Device: plate, fixation, bone
• Product Code: HRS
• Regulation Number: 888.3030
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
4-WEB, INC.
	SUBSTANTIALLY EQUIVALENT	1
4WEB MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
4WEB, INC.
	SUBSTANTIALLY EQUIVALENT	1
A PLUS BIOTECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
AAP IMPLANTATE AG
	SUBSTANTIALLY EQUIVALENT	22
ACUMED LLC
	SUBSTANTIALLY EQUIVALENT	10
ACUMED, LLC
	SUBSTANTIALLY EQUIVALENT	3
ACUTE INNOVATIONS LLC
	SUBSTANTIALLY EQUIVALENT	2
ADAPTIVE SPECIALTY, LLC
	SUBSTANTIALLY EQUIVALENT	1
ADDITIVE ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
ADDITIVE ORTHOPAEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	3
ADDITIVE ORTHOPAEDICS, LLC.
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED ORTHOPAEDIC SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	3
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
	SUBSTANTIALLY EQUIVALENT	1
AESCULAP IMPLANT SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ARTHREX INC.
	SUBSTANTIALLY EQUIVALENT	12
ARTHREX, INC.
	SUBSTANTIALLY EQUIVALENT	12
ARTHROSURFACE, INC.
	SUBSTANTIALLY EQUIVALENT	4
ASCENSION ORTHOPEDIC
	SUBSTANTIALLY EQUIVALENT	1
ASCENSION ORTHOPEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	4
AUXEIN MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
AUXEIN MEDICAL PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	4
AVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
	SUBSTANTIALLY EQUIVALENT	1
AVANTI ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
BIOMEDICAL ENTERPRISES, INC
	SUBSTANTIALLY EQUIVALENT	1
BIOMEDICAL ENTERPRISES, INC.
	SUBSTANTIALLY EQUIVALENT	1
BIOMET
	SUBSTANTIALLY EQUIVALENT	1
BIOMET INC
	SUBSTANTIALLY EQUIVALENT	1
BIOMET INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET MANUFACTURING
	SUBSTANTIALLY EQUIVALENT	1
BIOMET MANUFACTURING CORP.
	SUBSTANTIALLY EQUIVALENT	4
BIOMET MICOFIXATION
	SUBSTANTIALLY EQUIVALENT	2
BIOMET MICROFIXATION
	SUBSTANTIALLY EQUIVALENT	10
BIOMET MICROFIXATION, INC.
	SUBSTANTIALLY EQUIVALENT	2
BIOMET TRAUMA
	SUBSTANTIALLY EQUIVALENT	1
BIOMET TRAUMA (AKA EBI, LP)
	SUBSTANTIALLY EQUIVALENT	3
BIOMET, INC.
	SUBSTANTIALLY EQUIVALENT	4
BIOPRO, INC.
	SUBSTANTIALLY EQUIVALENT	1
BODYCAD LABORATORIES INC.
	SUBSTANTIALLY EQUIVALENT	1
BODYCAD LABORATORIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
BONEBRIDGE AG
	SUBSTANTIALLY EQUIVALENT	4
CANWELL MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CARBOFIX ORTHOPEDICS LTD.
	SUBSTANTIALLY EQUIVALENT	6
CARBOFIX ORTHOPEDICS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU DINGJIAN MEDICAL APPLIANCE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD
	SUBSTANTIALLY EQUIVALENT	1
CITIEFFE S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
CONVENTUS ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	2
CONVENTUS ORTHOPAEDICS, INC
	SUBSTANTIALLY EQUIVALENT	1
CONVENTUS ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
CROSSROADS EXTEMITY SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	1
CROSSROADS EXTREMITY SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
CROSSROADS EXTREMITY SYSTEMS, LLC
	SUBSTANTIALLY EQUIVALENT	5
DEPUY ORTHOPAEDICS, INC.
	SUBSTANTIALLY EQUIVALENT	10
DEPUY SYNTHES
	SUBSTANTIALLY EQUIVALENT	10
DEROYAL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
DOUBLE MEDICAL TECHNOLOGY INC.
	SUBSTANTIALLY EQUIVALENT	2
EBI, L.P.
	SUBSTANTIALLY EQUIVALENT	1
EBI,LLC D/B/A BIOMET TRAUMA
	SUBSTANTIALLY EQUIVALENT	1
EMERGE MEDICAL
	SUBSTANTIALLY EQUIVALENT	7
EMINENT SPINE
	SUBSTANTIALLY EQUIVALENT	1
ENDEAVOR ORTHOPAEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
ENHATCH ORTHOPAEDICS LLC
	SUBSTANTIALLY EQUIVALENT	1
EPIC EXTREMITY, LLC
	SUBSTANTIALLY EQUIVALENT	3
EXACTECH, INC
	SUBSTANTIALLY EQUIVALENT	1
EXACTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
EXREMITY MEDICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	1
EXSOMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
EXTREMITY MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	3
EXTREMITY MEDICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	3
FIELD ORTHOPAEDICS PTY LTD
	SUBSTANTIALLY EQUIVALENT	1
FIXIER, S.A. DE C.V.
	SUBSTANTIALLY EQUIVALENT	1
FLOWER ORTHOPEDICS CORPORATION
	SUBSTANTIALLY EQUIVALENT	5
FORMA MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
FUSION INNOVATIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
FUSION ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
FUSION ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
FX SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
GENESIS FRACTURE CARE, INC.
	SUBSTANTIALLY EQUIVALENT	5
GLOBUS MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	6
GLW MEDICAL INC
	SUBSTANTIALLY EQUIVALENT	1
GM DOS REIS INDUSTRIA E COMERCIO LTDA
	SUBSTANTIALLY EQUIVALENT	3
GM DOS REIS INDUSTRIA E COMERICO LTDA.
	SUBSTANTIALLY EQUIVALENT	1
GPC MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
GPC MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	2
GRAHAM MEDICAL TECHNOLOGIES, L.L.C.
	SUBSTANTIALLY EQUIVALENT	1
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. DBA GRAMEDICA
	SUBSTANTIALLY EQUIVALENT	1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	3
GREENS SURGICALS PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
HANKIL TECH MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HOSPITAL EQUIPMENT MANUFACTURING COMPANY
	SUBSTANTIALLY EQUIVALENT	1
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	5
HOWMEDICA OSTEONICS CORP.
	SUBSTANTIALLY EQUIVALENT	7
I.T.S. GMBH
	SUBSTANTIALLY EQUIVALENT	4
I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH
	SUBSTANTIALLY EQUIVALENT	1
IBALANCE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
	SUBSTANTIALLY EQUIVALENT	2
IMPACT MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
IN2BONES SAS
	SUBSTANTIALLY EQUIVALENT	2
IN2BONES USA
	SUBSTANTIALLY EQUIVALENT	1
IN2BONES USA, LLC
	SUBSTANTIALLY EQUIVALENT	13
IN2BONESUSA, LLC
	SUBSTANTIALLY EQUIVALENT	2
INDUSTRIAS MEDICAS SAMPEDRO S.A.S
	SUBSTANTIALLY EQUIVALENT	1
INTAI TECHNOLOGY CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
INTEGRA LIFESCIENCES CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
INTERNAL FIXATION SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTRAUMA S.P.A
	SUBSTANTIALLY EQUIVALENT	1
JACE MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
JACE MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
JEIL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	23
JIANGSU BAIDE MEDICAL INTRUMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU IDEAL MEDICAL SCIENCE & TECHNOLOGY CO., LT
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
JM LONGYEAR MANUFACTURING, LLC D.B.A. ABLE MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	1
JM LONGYEAR MANUFACTURING, LLC D/B/A ABLE MEDICAL DEVICES
	SUBSTANTIALLY EQUIVALENT	2
KENS FINEMEDTECH SDN. BHD
	SUBSTANTIALLY EQUIVALENT	1
KLS MARTIN L.P.
	SUBSTANTIALLY EQUIVALENT	3
KLS MARTIN LP
	SUBSTANTIALLY EQUIVALENT	1
KLS-MARTIN L.P.
	SUBSTANTIALLY EQUIVALENT	4
KOROS USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
LAURA CATTABRIGA
	SUBSTANTIALLY EQUIVALENT	1
LEITH MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
LIFE SPINE
	SUBSTANTIALLY EQUIVALENT	2
LIFE SPINE INC.
	SUBSTANTIALLY EQUIVALENT	2
MAHE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
MAXXION MEDICAL, LLC / BAUMER SA
	SUBSTANTIALLY EQUIVALENT	1
MBD MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
MCGINLEY ORTHPAEDIC INNOVATIONS, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDARTIS AG
	SUBSTANTIALLY EQUIVALENT	28
MEDLINE INDUSTIRES, LP
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	3
MEDLINE INDUSTRIES, LP
	SUBSTANTIALLY EQUIVALENT	2
MEDLINE, INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEMOMETAL TECHNOLOGIES
	SUBSTANTIALLY EQUIVALENT	2
MERETE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	3
MERIL HEALTHCARE PVT. LTD.
	SUBSTANTIALLY EQUIVALENT	1
MIAMI DEVICE SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
MIAMI DEVICE SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	5
MICROWARE PRECISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
MIRUS, LLC
	SUBSTANTIALLY EQUIVALENT	2
MX ORTHOPEDICS, CORP.
	SUBSTANTIALLY EQUIVALENT	1
N.M.B. MEDICAL APPLICATIONS, LTD.
	SUBSTANTIALLY EQUIVALENT	1
NARANG MEDICAL LIMITED
	SUBSTANTIALLY EQUIVALENT	1
NARANG MEDICAL USA CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NEBULA SURGICAL PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A
	SUBSTANTIALLY EQUIVALENT	1
NEOORTHO PRODUTOS ORTOPEDICOS S/A
	SUBSTANTIALLY EQUIVALENT	1
NEOSTEO
	SUBSTANTIALLY EQUIVALENT	1
NETBIOLOGICS, LLC
	SUBSTANTIALLY EQUIVALENT	1
NEWCLIP TECHNICS
	SUBSTANTIALLY EQUIVALENT	18
NEWDEAL SAS
	SUBSTANTIALLY EQUIVALENT	4
NEXTREMITY SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	6
NORMED MEDIZIN-TECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	5
NOVASTEP
	SUBSTANTIALLY EQUIVALENT	3
NVISION BIOMEDICAL TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	2
ORTHO LIFE SYSTEMS PRIVATE LIMITED
	SUBSTANTIALLY EQUIVALENT	1
ORTHO SELECT IMPLANT TECHNOLOGY GESELLSCHAFT
	SUBSTANTIALLY EQUIVALENT	1
ORTHO SOLUTIONS LIMITED
	SUBSTANTIALLY EQUIVALENT	3
ORTHO SOLUTIONS UK LTD
	SUBSTANTIALLY EQUIVALENT	2
ORTHO-PRO LLC
	SUBSTANTIALLY EQUIVALENT	1
ORTHOCARE
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOFIX SRL
	SUBSTANTIALLY EQUIVALENT	3
ORTHOFIX, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOHELIX SURGICAL DESIGNS, INC.
	SUBSTANTIALLY EQUIVALENT	13
ORTHOPAEDIC IMPLANT COMPANY
	SUBSTANTIALLY EQUIVALENT	4
ORTHOPEDIATRICS, CORP
	SUBSTANTIALLY EQUIVALENT	3
ORTHOPEDIATRICS, CORP.
	SUBSTANTIALLY EQUIVALENT	6
ORTHOPEDIATRICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORTHOPRO LLC
	SUBSTANTIALLY EQUIVALENT	1
OSTEOMED
	SUBSTANTIALLY EQUIVALENT	4
OSTEOMED L.P.
	SUBSTANTIALLY EQUIVALENT	3
OSTEOMED LP
	SUBSTANTIALLY EQUIVALENT	3
OSTEONIC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PANTHEON MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
PARAGON 28
	SUBSTANTIALLY EQUIVALENT	2
PARAGON 28, INC.
	SUBSTANTIALLY EQUIVALENT	5
PEGA MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
PIONEER SURGICAL TECHNOLOGY, INC
	SUBSTANTIALLY EQUIVALENT	2
PIONEER SURGICAL TECHNOLOGY, INC D.B.A RESOLVE SURGICAL TECH
	SUBSTANTIALLY EQUIVALENT	1
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL
	SUBSTANTIALLY EQUIVALENT	1
RIVERPOINT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
S H PITKAR ORTHOTOOLS PVT LTD.
	SUBSTANTIALLY EQUIVALENT	1
SCIENCE FOR BIOMATERIALS
	SUBSTANTIALLY EQUIVALENT	2
SCIENCES ET BIO MATERIAUX (SBM)
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI MICROPORT ORTHOPEDICS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SHOULDER OPTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SIG MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	1
SIG MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SKELETAL DYNAMICS INC
	SUBSTANTIALLY EQUIVALENT	2
SKELETAL DYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	5
SKELETAL DYNAMICS, LLC
	SUBSTANTIALLY EQUIVALENT	8
SKY SURGICAL LLC
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW
	SUBSTANTIALLY EQUIVALENT	2
SMITH & NEPHEW, INC
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	25
SMV SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
SOLANA SURGICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SONOMA ORTHOPEDIC PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
STABILIZ ORTHOPAEDICS, LLC
	SUBSTANTIALLY EQUIVALENT	2
STRYKER
	SUBSTANTIALLY EQUIVALENT	2
STRYKER CORP.
	SUBSTANTIALLY EQUIVALENT	2
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	20
STRYKER LEIBINGER GMBH
	SUBSTANTIALLY EQUIVALENT	1
STRYKER LEIBINGER GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
STRYKER TRAUMA AG
	SUBSTANTIALLY EQUIVALENT	16
STUCKENBROCK MEDIZINTECHNIK GMBH
	SUBSTANTIALLY EQUIVALENT	1
SUSPENSION ORTHOPAEDIC SOLUTIONS, LLC
	SUBSTANTIALLY EQUIVALENT	3
SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SYNTEC SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES (USA)
	SUBSTANTIALLY EQUIVALENT	15
SYNTHES (USA) LLC
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES (USA) PRODUCTS LLC
	SUBSTANTIALLY EQUIVALENT	10
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES (USA) PRODUCTS, LLC
	SUBSTANTIALLY EQUIVALENT	5
SYNTHES GMBH
	SUBSTANTIALLY EQUIVALENT	2
SYNTHES INC
	SUBSTANTIALLY EQUIVALENT	1
SYNTHES USA
	SUBSTANTIALLY EQUIVALENT	6
TDM CO. LTD.
	SUBSTANTIALLY EQUIVALENT	3
TDM CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TECHFIT DIGITAL SURGERY INC.
	SUBSTANTIALLY EQUIVALENT	1
THE ORTHOPAEDIC IMPLANT COMPANY (OIC)
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN WALKMAN BIOMATERIAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
TOBY ORTHOPAEDICS
	SUBSTANTIALLY EQUIVALENT	1
TORNIER INC.
	SUBSTANTIALLY EQUIVALENT	2
TORNIER, INC.
	SUBSTANTIALLY EQUIVALENT	2
TREACE MEDICAL CONCEPTS INC.
	SUBSTANTIALLY EQUIVALENT	2
TREACE MEDICAL CONCEPTS, INC.
	SUBSTANTIALLY EQUIVALENT	7
TRIDENT ORTHOPEDICS
	SUBSTANTIALLY EQUIVALENT	1
TRILLIANT SURGICAL
	SUBSTANTIALLY EQUIVALENT	2
TRILLIANT SURGICAL LTD
	SUBSTANTIALLY EQUIVALENT	3
TRILLIANT SURGICAL, LTD
	SUBSTANTIALLY EQUIVALENT	2
TRIMED, INC
	SUBSTANTIALLY EQUIVALENT	1
TRIMED, INC.
	SUBSTANTIALLY EQUIVALENT	9
TRUEMED GROUP LLC
	SUBSTANTIALLY EQUIVALENT	2
TRUEMED GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1
TYBER MEDICAL LLC
	SUBSTANTIALLY EQUIVALENT	2
TYBER MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	2
TYBER MEDICAL, LLC.
	SUBSTANTIALLY EQUIVALENT	4
VILEX LLC
	SUBSTANTIALLY EQUIVALENT	3
VILEX, LLC
	SUBSTANTIALLY EQUIVALENT	1
WEIGAO ORTHOPAEDIC DEVICE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
WISHBONE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
WRIGHT MEDICAL TECHNOLOGY, INC.
	SUBSTANTIALLY EQUIVALENT	32
XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
XIAMEN DOUBLE ENGLINE MEDICAL MATERIAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER GMBH
	SUBSTANTIALLY EQUIVALENT	4
ZIMMER INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER SWITZERLAND MANUFACTURING GMBH
	SUBSTANTIALLY EQUIVALENT	1
ZIMMER, INC.
	SUBSTANTIALLY EQUIVALENT	13
ZIMMER,INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	2412	2412
2015	3093	3093
2016	2276	2276
2017	2216	2216
2018	2663	2663
2019	3356	3356
2020	2790	2790
2021	2443	2443
2022	1700	1703
2023	2058	2058
2024	1300	1302

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	10281	10285
Break	5561	5563
Fracture	1889	1891
Insufficient Information	815	815
Device-Device Incompatibility	740	740
Migration or Expulsion of Device	713	713
Migration	642	642
Device Operates Differently Than Expected	538	538
Appropriate Term/Code Not Available	503	503
Device Dislodged or Dislocated	366	366
Device Slipped	349	349
Fitting Problem	262	262
Material Twisted/Bent	235	235
No Apparent Adverse Event	224	224
Difficult to Remove	211	211
Loose or Intermittent Connection	205	205
Material Deformation	194	194
Patient-Device Incompatibility	187	187
Material Fragmentation	166	166
Loosening of Implant Not Related to Bone-Ingrowth	162	162
Unintended Movement	159	159
Detachment of Device or Device Component	159	159
Packaging Problem	151	151
Malposition of Device	145	145
Use of Device Problem	144	144
Difficult to Insert	139	139
Detachment Of Device Component	138	138
Positioning Failure	133	133
Crack	133	133
Positioning Problem	119	119
Corroded	113	113
Patient Device Interaction Problem	112	112
Bent	111	111
Physical Resistance/Sticking	104	104
Mechanical Problem	104	104
Delivered as Unsterile Product	98	98
Manufacturing, Packaging or Shipping Problem	98	98
Failure To Adhere Or Bond	92	92
Improper or Incorrect Procedure or Method	89	89
Entrapment of Device	87	87
Failure to Osseointegrate	86	86
Device Inoperable	77	77
Connection Problem	73	73
Defective Device	72	72
Osseointegration Problem	69	69
Component Missing	63	63
Device Markings/Labelling Problem	62	62
Inadequacy of Device Shape and/or Size	62	62
Dull, Blunt	57	57
Failure to Align	56	56

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Code Available	4957	4957
Pain	3497	3498
Non-union Bone Fracture	3106	3107
Failure of Implant	3007	3009
No Known Impact Or Consequence To Patient	2509	2509
Unspecified Infection	2355	2356
No Clinical Signs, Symptoms or Conditions	1821	1821
Impaired Healing	1345	1345
Bone Fracture(s)	1307	1308
No Information	1001	1001
Insufficient Information	826	826
No Consequences Or Impact To Patient	755	755
Injury	647	647
Discomfort	619	619
Loss of Range of Motion	592	592
Necrosis	503	503
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	439	439
Post Operative Wound Infection	432	432
Foreign Body In Patient	415	416
Device Embedded In Tissue or Plaque	406	406
No Patient Involvement	327	327
Nerve Damage	309	309
Swelling	250	250
Wound Dehiscence	236	236
Implant Pain	217	217
Irritation	201	201
Arthritis	201	201
Reaction	200	200
Skin Inflammation/ Irritation	189	189
Hypersensitivity/Allergic reaction	186	186
Fall	185	185
Malunion of Bone	177	177
Physical Asymmetry	173	173
Swelling/ Edema	132	132
Inflammation	129	129
Hematoma	117	117
Unspecified Tissue Injury	116	116
Sedation	97	97
Osteolysis	96	96
Rupture	92	92
Tissue Damage	90	90
Ossification	90	90
Muscular Rigidity	85	85
Deformity/ Disfigurement	85	85
Joint Dislocation	80	80
Muscle/Tendon Damage	75	75
Skin Irritation	73	73
Hemorrhage/Bleeding	72	73
Limited Mobility Of The Implanted Joint	69	69
Perforation	61	61

Recalls
Manufacturer		Recall Class	Date Posted
1	ACUTE Innovations, LLC	II	Jan-28-2014
2	Acumed LLC	II	Feb-29-2024
3	Acumed LLC	II	Feb-14-2017
4	Acumed LLC	II	Apr-25-2014
5	Acumed LLC	II	Jun-16-2010
6	Acute Innovations Llc	II	Dec-01-2011
7	Arthrex, Inc.	II	Apr-09-2021
8	Arthrex, Inc.	II	Jul-29-2020
9	Arthrex, Inc.	II	Apr-08-2016
10	Biomet	II	Jun-09-2020
11	Biomet Microfixation, Inc.	II	Jan-24-2012
12	Biomet Microfixation, Inc.	II	May-27-2009
13	Biomet, Inc.	II	Jan-21-2021
14	Biomet, Inc.	II	May-26-2016
15	Biomet, Inc.	II	Dec-18-2015
16	Biomet, Inc.	II	Jul-10-2015
17	Biomet, Inc.	II	Jul-08-2015
18	Biomet, Inc.	II	Aug-13-2014
19	Biomet, Inc.	II	Jan-10-2014
20	Biomet, Inc.	II	Apr-19-2012
21	Depuy Orthopaedics, Inc.	II	Mar-07-2011
22	Depuy Orthopaedics, Inc.	II	Feb-11-2009
23	Epic Extremity, LLC	II	May-15-2018
24	Flower Orthopedics Corporation	II	Oct-06-2021
25	Flower Orthopedics Corporation	II	Aug-12-2020
26	GRAMERCY EXTREMITY ORTHOPEDICS	II	Apr-17-2023
27	I.T.S. GmbH	II	Jun-04-2019
28	In2Bones, SAS	II	Aug-03-2017
29	In2Bones, SAS	II	Jan-06-2017
30	Integra LifeSciences Corp.	II	Jun-14-2016
31	Integra LifeSciences Corp.	II	Aug-01-2012
32	Integra LifeSciences Corp.	II	Mar-02-2012
33	Integra LifeSciences Corp.	II	Jan-25-2011
34	K2M, Inc	II	Apr-12-2021
35	Miami Device Solutions, LLC.	II	Dec-05-2019
36	NewDeal SA	II	Jul-16-2018
37	Nextremity Solutions	II	Feb-11-2020
38	Nextremity Solutions	II	Nov-22-2019
39	OrthoPediatrics Corp	II	Sep-18-2015
40	OrthoPediatrics Corp	II	Nov-14-2013
41	OrthoPediatrics Corp	II	Nov-22-2012
42	OrthoPediatrics Corp	II	Jul-20-2012
43	Orthofix, Inc	II	Jun-07-2018
44	Orthohelix Surgical Designs Inc	II	Jan-11-2012
45	Orthohelix Surgical Designs Inc	II	Aug-29-2011
46	Paragon 28, Inc.	II	Jul-25-2022
47	Smith & Nephew Inc	II	Aug-31-2010
48	Smith & Nephew, Inc.	II	Feb-01-2022
49	Smith & Nephew, Inc.	II	Dec-10-2021
50	Smith & Nephew, Inc.	II	Nov-18-2021
51	Smith & Nephew, Inc.	II	Sep-09-2020
52	Smith & Nephew, Inc.	II	Jan-24-2018
53	Smith & Nephew, Inc.	II	Jan-19-2018
54	Smith & Nephew, Inc.	II	Apr-18-2017
55	Smith & Nephew, Inc.	II	Apr-14-2017
56	Smith & Nephew, Inc.	II	Dec-04-2015
57	Stryker GmbH	II	Jan-07-2020
58	Stryker Howmedica Osteonics Corp.	II	Feb-16-2011
59	Stryker Howmedica Osteonics Corp.	II	Apr-13-2009
60	Synthes (USA) Products LLC	II	Mar-01-2024
61	Synthes (USA) Products LLC	II	Aug-17-2020
62	Synthes (USA) Products LLC	II	Aug-11-2016
63	Synthes (USA) Products LLC	II	Jun-10-2016
64	Synthes (USA) Products LLC	II	Nov-06-2015
65	Synthes (USA) Products LLC	II	Oct-30-2015
66	Synthes (USA) Products LLC	II	Oct-15-2015
67	Synthes (USA) Products LLC	II	Nov-27-2013
68	Synthes (USA) Products LLC	II	Aug-26-2013
69	Synthes Spine	II	Jun-01-2009
70	Synthes Spine	II	May-21-2009
71	Synthes USA (HQ), Inc.	II	Nov-02-2010
72	Synthes USA (HQ), Inc.	II	Feb-24-2010
73	Synthes USA HQ, Inc.	II	Nov-22-2013
74	Synthes USA HQ, Inc.	II	Aug-26-2013
75	Synthes USA HQ, Inc.	II	Jun-19-2013
76	Synthes USA HQ, Inc.	II	Mar-15-2013
77	Synthes, Inc.	II	Jan-29-2020
78	Synthes, Inc.	II	Mar-25-2014
79	Synthes, Inc.	II	Mar-11-2014
80	Toby Orthopaedics, Inc.	II	Dec-04-2019
81	Treace Medical Concepts, Inc.	II	Aug-23-2024
82	TriMed Inc.	II	Jan-31-2024
83	TriMed Inc.	II	Nov-13-2019
84	TriMed Inc.	II	Oct-10-2019
85	TriMed Inc.	II	Apr-23-2019
86	TriMed Inc.	II	Aug-18-2018
87	Trilliant Surgical Ltd.	II	Sep-04-2015
88	Trilliant Surgical Ltd.	II	Aug-31-2015
89	Trimed Inc	II	Sep-20-2016
90	Wishbone Medical, Inc.	II	Jun-04-2021
91	Wright Medical Technology Inc	II	Dec-17-2021
92	Wright Medical Technology Inc	II	Aug-09-2010
93	Wright Medical Technology, Inc.	II	Apr-26-2023
94	Wright Medical Technology, Inc.	II	Feb-24-2023
95	Wright Medical Technology, Inc.	II	Mar-15-2022
96	Wright Medical Technology, Inc.	II	Feb-25-2022
97	Wright Medical Technology, Inc.	II	Dec-20-2021
98	Wright Medical Technology, Inc.	II	Nov-25-2019
99	Wright Medical Technology, Inc.	II	Sep-01-2015
100	Wright Medical Technology, Inc.	II	Apr-22-2015