Kirschner Self-Tapping Acetabular Cup
FDA 510(k) K852351 · Kirschner Medical Corp.
510(k) numberK852351
Submission
- Device name
- Kirschner Self-Tapping Acetabular Cup
- Applicant
- Kirschner Medical Corp.
Timonium, MD, US - Received
- May 31, 1985
- Decision date
- August 9, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K940537 | Kirschner(R) Modular Ii-C(Tm) Total Shoulder SystemKWT · Traditional | 08/29/1995SE |
| K936274 | Kirschner Performance Posterior Stabilized Total Knee SystemJWH · Traditional | 01/18/1995SE |
| K942891 | Summit Total Hip SystemMEH · Traditional | 11/02/1994SE |
| K941486 | Integrity Total Hip System, Non-PorousJDI · Traditional | 09/20/1994SE |
| K933843 | Line Extension for Kirschner Performance Total Knee System, Porous CoatedJWH · Traditional | 08/05/1994SE |
| K935951 | Kirschner C-2 Osteocap Total Hip SystemJDI · Traditional | 07/18/1994SE |
| K935206 | Kirschner Integrity Acetabular Cup ModificationJDI · Traditional | 07/13/1994SE |
| K934589 | Kirschner Performance Total Knee System Porous CoatedJWH · Traditional | 07/13/1994SN |
| K934694 | Kirschner Zirconia Femoral HeadLZO · Traditional | 05/18/1994SE |
| K920188 | Threaded PinsMBJ · Traditional | 05/12/1993SE |
Questions and answers
When was Kirschner Self-Tapping Acetabular Cup cleared by the FDA?
Kirschner Self-Tapping Acetabular Cup (K852351) received a 510(k) decision of Substantially Equivalent on August 9, 1985, 70 days after the submission was received.
What is the product code of K852351?
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.