Austin Moore Type Hip Prothesis
FDA 510(k) K905349 · O'Tec Corp.
510(k) numberK905349
Submission
- Device name
- Austin Moore Type Hip Prothesis
- Applicant
- O'Tec Corp.
Memphis, TN, US - Received
- November 28, 1990
- Decision date
- December 11, 1990
- 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
Other 510(k)s with product code KWL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Osteoremedies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K943293 | SCC22/ SCC26 Shower Commode ChairIOR · Traditional | 08/19/1994SE |
| K910093 | Futura Femoral Hip StemJDI · Traditional | 07/01/1991SE |
| K905358 | Cancellous ScrewHWC · Traditional | 01/04/1991SN |
| K905357 | Cortical Bone Screw (European Style)HWC · Traditional | 01/04/1991SN |
| K905355 | Broad Self-Compressing PlateHRS · Traditional | 01/04/1991SN |
| K905347 | Hagie PinJDW · Traditional | 01/04/1991SN |
| K905333 | U.S. Type Cruciate Slot Bone ScrewHWC · Traditional | 01/04/1991SN |
| K905364 | Round StapleJDR · Traditional | 12/11/1990SE |
| K905363 | Fixation StapleJDR · Traditional | 12/11/1990SE |
| K905362 | Barbed Square StapleJDR · Traditional | 12/11/1990SE |
Questions and answers
When was Austin Moore Type Hip Prothesis cleared by the FDA?
Austin Moore Type Hip Prothesis (K905349) received a 510(k) decision of Substantially Equivalent on December 11, 1990, 13 days after the submission was received.
What is the product code of K905349?
The FDA product code is KWL – Prosthesis, Hip, Hemi-, Femoral, Metal, a Class II (moderate risk) device regulated under 21 CFR 888.3360.