Prosthesis, Tendon, Passive
A passive tendon prosthesis is a surgically implanted device used as a temporary spacer to maintain the tendon sheath and gliding tissue in preparation for later tendon grafting, or as a permanent substitute for a damaged tendon in selected cases. It is classified as an FDA Class 2 device under 21 CFR 888.3025, indicating moderate risk and requiring 510(k) premarket clearance. Product code HXA falls under the Orthopedic medical specialty. This device is an implant.
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Basic Information
- Product Code
- HXA
- Device Class
- FDA class 2
- Regulation Number
- 888.3025
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K243477 | Universal Tendon Spacer | Jan 10, 2025 | Substantially Equivalent | Askorn Medical |
| K000019 | SINGLE SIZE TENDON SPACER | Mar 29, 2000 | Substantially Equivalent | Medist International |
| K973385 | OVAL SHAPES | Dec 05, 1997 | Substantially Equivalent | Technical Products, Inc. |
| K964359 | AVANTA ORTHOPAEDICS TENDON SPACER | Mar 25, 1997 | Substantially Equivalent | Avanta Orthopaedics, Inc. |
| K930125 | PHOENIX BONE SCREWS PBS-TYPE SERIES | Dec 30, 1993 | Substantially Equivalent | Phoenix Bioengineering, Inc. |
| K872293 | H-H HUNTER ACTIVE TENDON IMPLANT BC | Sep 28, 1987 | Substantially Equivalent for Some Indications | Holter-Hausner Intl. |
| K872285 | H-H HUNTER ACTIVE TENDON IMPLANT DC | Sep 28, 1987 | Substantially Equivalent for Some Indications | Holter-Hausner Intl. |
| K872284 | H-H HUNTER ACTIVE TENDON IMPLANT PC | Sep 28, 1987 | Substantially Equivalent for Some Indications | Holter-Hausner Intl. |
| K853438 | H-H HUNTER ACTIVE TENDON IMPLANT | Sep 30, 1985 | Substantially Equivalent for Some Indications | Holter-Hausner Intl. |
| K781943 | TENDON ROD MODEL OR41PO3-6 | Dec 04, 1978 | Substantially Equivalent | Holter-Hausner Intl. |
| K780320 | PASSIVE TENDON IMPLANT | Mar 17, 1978 | Substantially Equivalent | Holter-Hausner Intl. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.