E1 ANTIOXIDANT INFUSED TECHNOLOGY
FDA 510(k) clearance K100048 · decided 2010-03-09
Clearance details
- K-number
- K100048
- Device name
- E1 ANTIOXIDANT INFUSED TECHNOLOGY
- Applicant
- Biomet Manufacturing Corp
- Decision
- Substantially Equivalent
- Date received
- 2010-01-08
- Decision date
- 2010-03-09
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- OIY
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| DePuy ATTUNE™ Knee System (K252887) | DePuy Orthopaedics, Inc. | 2026-05-22 |
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| DePuy ATTUNE™ Total Knee System (K201347) | DePuy Orthopaedics, Inc. | 2020-06-18 |
| A200 KNEE SYSTEM (K120038) | Renovis Surgical Technologies, LLC | 2013-02-14 |
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| HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA (K113756) | Encore Medical L.P. | 2012-03-14 |
| DEPUY STTUNE (TM) PS KNEE SYSTEM (K111433) | DePuy Orthopaedics, Inc. | 2011-08-30 |
| DEPUY ATTUNE TOTAL KNEE SYSTEM (K103756) | DePuy Orthopaedics, Inc. | 2011-03-15 |
| HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS (K103223) | Encore Medical L.P. | 2010-12-21 |
| DEPUY ATTUNE KNEE SYSTEM (K101433) | DePuy Orthopaedics, Inc. | 2010-12-10 |
| HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712 (K091956) | Encore Medical L.P. | 2010-09-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Oxford Knee System (P010014/S111) | Biomet Manufacturing Corp | 2025-08-07 |
| Oxford Partial Knee System (P010014/S109) | Biomet Manufacturing Corp | 2025-08-07 |
| OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEM (P010014/S110) | Biomet Manufacturing Corp | 2025-06-24 |
| Oxford® Partial Knee System (P010014/S107) | Biomet Manufacturing Corp | 2024-11-22 |
| Oxford Cementless Partial Knee System (P010014/S105) | Biomet Manufacturing Corp | 2024-11-22 |
| Oxford Partial Knee System (P010014/S108) | Biomet Manufacturing Corp | 2024-11-18 |
| Oxford® Partial Knee System (P010014/S106) | Biomet Manufacturing Corp | 2024-08-19 |
| Oxford Partial Knee (P010014/S104) | Biomet Manufacturing Corp | 2023-04-06 |