Taperloc Complete
FDA 510(k) K101086 · Biomet, Inc.
510(k) numberK101086
Submission
- Device name
- Taperloc Complete
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- April 19, 2010
- Decision date
- September 3, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 888.3330
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K122778 | Profemur Z Revision Hip StemKWA · Special | Wrightmedicaltechnologyinc | 10/11/2012SE |
| K121544 | Dynasty Biofoam ShellKWA · Traditional | Wrightmedicaltechnologyinc | 07/30/2012SE |
| K113271 | Metal-On-Metal Hip Systems-Additional ContraindicationsKWA · Traditional | Biomet Manufacturing, Inc. | 05/18/2012SE |
| K113322 | Conserve Thin ShellKWA · Special | Wrightmedicaltechnologyinc | 02/03/2012SE |
| K112080 | Preserve Hip StemKWA · Special | Wrightmedicaltechnologyinc | 12/28/2011SE |
| K112150 | Profemur Gladiator Ha Hip StemKWA · Traditional | Wrightmedicaltechnologyinc | 11/23/2011SE |
| K113019 | Profemur XM Wingless Distal Centralizer, Perfecta Distal CentralizerKWA · Special | Wrightmedicaltechnologyinc | 11/10/2011SE |
| K111910 | Gladiator Hip StemKWA · Traditional | Wrightmedicaltechnologyinc | 10/14/2011SE |
| K110836 | CLS Brevius Stem with Kinectiv TechnologyKWA · Traditional | Zimmer GmbH | 10/07/2011SE |
| K110400 | Taperloc Complete Microplasty StemKWA · Traditional | Biomet Manufacturing Corp | 09/30/2011SE |
More from Biomet Manufacturing Corp
| 510(k) | Device | Decision |
|---|---|---|
| K253434 | OSSTM Orthopedic Salvage SystemJDI · Traditional | 07/01/2026SE |
| K251270 | Taperloc® Complete Hip StemLPH · Traditional | 05/19/2026SE |
| K241014 | Biomet Kirschner Wires (K-Wires)HTY · Traditional | 05/22/2024SE |
| K222760 | StageOne Select Hip Cement Spacer MoldsMBB · Traditional | 12/28/2022SE |
| K221968 | StageOne Shoulder Cement Spacer MoldsMBB · Traditional | 09/15/2022SE |
| K213287 | StageOne Knee Cement Spacer MoldsMBB · Traditional | 09/02/2022SE |
| K212431 | Biomet Answer/Impact/Integral Distal Centralizer/Centering SleeveJDG · Traditional | 02/07/2022SE |
| K212435 | Comprehensive Humeral Fracture Positioning SleevesKWS · Traditional | 12/10/2021SE |
| K210192 | A.L.P.S. Clavicle Plating SystemHRS · Special | 02/19/2021SE |
| K193214 | WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System…MBI · Traditional | 11/10/2020SE |
Questions and answers
When was Taperloc Complete cleared by the FDA?
Taperloc Complete (K101086) received a 510(k) decision of Substantially Equivalent on September 3, 2010, 137 days after the submission was received.
What is the product code of K101086?
The FDA product code is KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3330.