Recognition List Number: 020 Publication Date: 09/09/2008
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-207: ASTM F2193-02(2007), Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System. (Orthopaedics)
Date of Standard: 2007. |
| Address of Standards Organization: |
| ASTM International (ASTM) |
| 100 Barr Harbor Drive |
| West Conshohocken, PA 19428-2959 |
| |
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Metallic spinal screw, metallic spinal plate and metallic spinal rod components intended for posterior (interlaminal), anterior/anteriolateral (intervertebral body), and posterior (pedicle) fixation. |
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| Processes Affected: |
| 510(k), HDE, IDE, PMA, PDP, Design Controls |
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| Type of Standard: |
| Test Methods, National, Vertical |
| Extent of Recognition: |
Complete standard
Test methods provide examples of acceptable types of static and fatigue test methods for the characterization of metallic spinal screws, plates and rods intended for posterior (interlaminal), anterior/anteriolateral (intervertebral body), and posterior (pedicle) fixation. Additional information should be provided to document that the design of the product will provide adequate mechanical properties for the particular application. Additional testing should be performed to evaluate the interconnections between individual components and subassemblies and to evaluate whole constructs (spinal implant assemblies attached to a spine model). Where the standard allows the user to select test parameters, additional information should be provided to describe and justify the test parameters selected. In applications subjected to wear or articulation, additional data should be provided to document resistance to wear and abrasion. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Orthosis, Cervical Pedicle Screw Spinal Fixation |
Class U |
NKG |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3050 |
Appliance, Fixation, Spinal Interlaminal |
Class 2 |
KWP |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3060 |
Appliance, Fixation, Spinal Intervertebral Body |
Class 2 |
KWQ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3070 |
Orthosis, Spinal Pedicle Fixation |
Class 2 |
MNI |
| §888.3070 |
Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease |
Class 3 |
NKB |
| §888.3070 |
Orthosis, Spondylolisthesis Spinal Fixation |
Class 2 |
MNH |
| |
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| Relevant Guidance: |
Guidance for Industry and FDA Staff Spinal System 510(k)s, May 3, 2004
Guidance for Industry and/or FDA Reviewers/Staff - Guidance Document for the Preparation of IDEs for Spinal Systems, January 13, 2000 |
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| FDA Technical Contact: |
| Jonathan Peck |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 1418 |
| Silver Spring MD 20993 |
| 301/796-5650 |
| Email: jonathan.peck@fda.hhs.gov |
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