Recognition List Number: 029 Publication Date: 08/20/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 11-185: ASTM F2267-04 (Reapproved 2011), Standard Test Method for Measuring Load Induced Subsidence of Intervertebral Body Fusion Device Under Static Axial Compression. (Orthopaedics)
Date of Standard: 2004. |
| 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: |
| This standard contains test methods that are potentially relevant to any device that could feasibly subside into a vertebral body. While the scope of the standard is limited to testing of intervertebral body fusion devices, other devices commonly tested using the methods described in this standard include vertebral body replacement devices and total artificial disc replacements. |
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| Processes Affected: |
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| Type of Standard: |
| Test Methods, National, Vertical |
| Extent of Recognition: |
| Complete Standard. This standard describes test methods for axial compressive subsidence testing. |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Prosthesis, Intervertebral Disc |
Class 3 |
MJO |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3060 |
Spinal Vertebral Body Replacement Device |
Class 2 |
MQP |
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Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §888.3080 |
Intervertebral Fusion Device With Bone Graft, Cervical |
Class 2 |
ODP |
| §888.3080 |
Intervertebral Fusion Device With Bone Graft, Lumbar |
Class 2 |
MAX |
| §888.3080 |
Intervertebral Fusion Device With Integrated Fixation, Cervical |
Class 2 |
OVE |
| §888.3080 |
Intervertebral Fusion Device With Integrated Fixation, Lumbar |
Class 2 |
OVD |
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| Relevant Guidance: |
Guidance for Industry and FDA Staff - Preparation and Review of Investigational
Device Exemption Applications (IDEs) for Total Artificial Discs, April 11, 2008
Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document:
Intervertebral Body Fusion Device, June 12, 2007
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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