TF-II HIP PROSTHESIS
FDA 510(k) clearance K843995 · decided 1985-04-23
Clearance details
- K-number
- K843995
- Device name
- TF-II HIP PROSTHESIS
- Applicant
- Dow Corning Corp. Healthcare Industries Materials
- Decision
- Substantially Equivalent
- Date received
- 1984-10-11
- Decision date
- 1985-04-23
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- KWL
- Device class
- 2
- Regulation number
- 888.3360
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- P.O. Box 1767 Midland, MI, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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|---|---|---|
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| InterSpace GV Hip Spacer (K252326) | Tecres S.P.A. | 2025-08-06 |
| Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer (K242865) | Biocomposites, Ltd. | 2025-06-12 |
| COPAL® exchange G hip spacer; COPAL® G+V (K234028) | Heraeus Medical GmbH | 2024-02-15 |
| UHR Bipolar Implants, Restoration GAP II Implants (K222632) | Howmedica Osteonics Corp., Dba Stryker Orthopaedics | 2022-10-21 |
| OsteoRemedies Hip Spacer System (K192995) | Osteoremedies, LLC | 2020-01-10 |
| REMEDY Acetabular Cup (K191981) | Osteoremedies, LLC | 2019-08-23 |
| REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement (K172906) | Osteoremedies, LLC | 2018-08-29 |
| Remedy Acetabular Cup (K173967) | Osteoremedies, LLC | 2018-02-22 |
| Evolve UniPolar Head (K143184) | Signature Orthopaedics Pty, Ltd. | 2015-03-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| THE SOFT RINSE SYSTEM (P800060/S007) | Dow Corning Corp. Healthcare Industries Materials | 1991-03-05 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S010) | Dow Corning Corp. Healthcare Industries Materials | 1985-11-18 |
| SILSOFT (ELASTOFILCON A ) CONTACT LENS (P800020/S007) | Dow Corning Corp. Healthcare Industries Materials | 1985-11-05 |
| THE SOFT RINSE SYSTEM (P800060/S006) | Dow Corning Corp. Healthcare Industries Materials | 1985-07-30 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S008) | Dow Corning Corp. Healthcare Industries Materials | 1984-10-31 |
| THE SOFT RINSE SYSTEM (P800060/S005) | Dow Corning Corp. Healthcare Industries Materials | 1984-04-04 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S009) | Dow Corning Corp. Healthcare Industries Materials | 1984-03-12 |
| SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR (P800054/S004) | Dow Corning Corp. Healthcare Industries Materials | 1983-11-09 |