Healey Revision Component System
FDA 510(k) K921139 · Biomet, Inc.
510(k) numberK921139
Submission
- Device name
- Healey Revision Component System
- Applicant
- Biomet, Inc.
Warsaw, IN, US - Received
- March 10, 1992
- Decision date
- July 1, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JDL – Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)
- Device class
- Class III (high risk)
- Regulation
- 21 CFR 888.3320
- Specialty
- Orthopedic
- Implant
- Yes
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|---|---|---|---|
| K073499 | Versys Epoch Fullcoat Hip Prosthesis, Model 4088 SeriesJDL · Traditional | Zimmer, Inc. | 08/07/2008SE |
| K070785 | Dynasty Acetabular SystemJDL · Special | Wrightmedicaltechnologyinc | 07/11/2007SE |
| K061844 | Dynasty Acetabular Shell and Cocr Acetabular LinerJDL · Special | Wrightmedicaltechnologyinc | 12/06/2006SE |
| K051995 | Profemur Renaissance Hip StemJDL · Special | Wrightmedicaltechnologyinc | 08/22/2005SE |
| K051348 | Conserve Total Femoral HeadJDL · Traditional | Wrightmedicaltechnologyinc | 08/19/2005SE |
| K042841 | M2A/C2A Acetabular SystemJDL · Traditional | Biomet, Inc. | 12/21/2004SE |
| K041586 | Profemur S Hip StemJDL · Special | Wrightmedicaltechnologyinc | 07/09/2004SE |
| K041114 | Profemur Tapered Hip StemJDL · Special | Wrightmedicaltechnologyinc | 05/28/2004SE |
| K004043 | Metal Transcend Articulation SystemJDL · Abbreviated | Wrightmedicaltechnologyinc | 07/13/2001SE |
| K950542 | Metal Backed Acetabular ComponentJDL · Traditional | Encore Orthopedics, Inc. | 05/25/1995SE |
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Questions and answers
When was Healey Revision Component System cleared by the FDA?
Healey Revision Component System (K921139) received a 510(k) decision of Substantially Equivalent on July 1, 1992, 113 days after the submission was received.
What is the product code of K921139?
The FDA product code is JDL – Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3320.