MTS Femoral Hip System
FDA 510(k) K903877 · 3M Company
510(k) numberK903877
Submission
- Device name
- MTS Femoral Hip System
- Applicant
- 3M Company
Cottae Grove, MN, US - Received
- August 22, 1990
- Decision date
- January 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWL – Prosthesis, Hip, Hemi-, Femoral, Metal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
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| K262290 | REMEDY POLY+PLUS SNAP FIT Acetabular CupKWL · Special | Osteoremedies, LLC | 07/24/2026SE |
| K260536 | Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone CementKWL · Traditional | Depuy Ireland UC | 05/15/2026SE |
| K253675 | OsteoRemedies Hip Spacer SystemKWL · Special | Osteoremedies, LLC | 12/23/2025SE |
| K252326 | InterSpace GV Hip SpacerKWL · Special | Tecres S.P.A. | 08/06/2025SE |
| K242865 | Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder SpacerKWL · Traditional | Biocomposites, Ltd. | 06/12/2025SE |
| K234028 | COPAL® exchange G hip spacer; COPAL® G+VKWL · Traditional | Heraeus Medical GmbH | 02/15/2024SE |
| K222632 | UHR Bipolar Implants, Restoration GAP II ImplantsKWL · Traditional | Howmedica Osteonics Corp., Dba Stryker… | 10/21/2022SE |
| K192995 | OsteoRemedies Hip Spacer SystemKWL · Special | Osteoremedies, LLC | 01/10/2020SE |
| K191981 | REMEDY Acetabular CupKWL · Special | Osteoremedies, LLC | 08/23/2019SE |
| K172906 | REMEDY PLUS Hip Spacer, UNITE PLUS Bone CementKWL · Traditional | Osteoremedies, LLC | 08/29/2018SE |
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| K241542 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)FRC · Special | 06/27/2024SE |
| K240717 | 3M Attest Rapid Readout Biological Indicator 1295 and 3M Attest Vaporized Hydrogen…FRC · Special | 06/27/2024SE |
| K233814 | 3M Attest Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3M…FRC · Traditional | 03/15/2024SE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)KKX · Traditional | 05/18/2023SE |
| K222508 | 3M Comply Hydrogen Peroxide Chemical Indicator 1248JOJ · Traditional | 11/01/2022SE |
| K222152 | 3M Attest Hydrogen Peroxide Indicator Tape 1228JOJ · Traditional | 09/23/2022SE |
Questions and answers
When was MTS Femoral Hip System cleared by the FDA?
MTS Femoral Hip System (K903877) received a 510(k) decision of Substantially Equivalent on January 18, 1991, 149 days after the submission was received.
What is the product code of K903877?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.