Zirconia Prozyr Ceramic 12/14 Global Taper (GT) Femoral Heads
FDA 510(k) K971414 · Smith & Nephew, Inc., Orthopaedic Div.
510(k) numberK971414
Submission
- Device name
- Zirconia Prozyr Ceramic 12/14 Global Taper (GT) Femoral Heads
- Applicant
- Smith & Nephew, Inc., Orthopaedic Div.
Memphis, TN, US - Received
- April 16, 1997
- Decision date
- July 16, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3353
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253948 | Momentum Acetabular Cup SystemLZO · Traditional | United Orthopedic Corporation | 09/02/2026SE |
| K261009 | MobileLink Acetabular Cup System 40mm ID Inserts (various)LZO · Traditional | Waldemar Link GmbH & Co. KG | 07/06/2026SE |
| K260831 | Z1 Hip SystemLZO · Traditional | Zimmer, Inc. | 06/16/2026SE |
| K260182 | Avenir® Müller Stem; Avenir Complete Hip SystemLZO · Traditional | Zimmer, Inc. | 04/27/2026SE |
| K260037 | implantcast Packaging System UpdateLZO · Traditional | Implantcast GmbH | 03/30/2026SE |
| K252401 | implaFit® short stemsLZO · Traditional | Implantcast GmbH | 03/12/2026SE |
| K253171 | Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)LZO · Traditional | Maxx Orthopedics, Inc. | 01/15/2026SE |
| K250450 | Coated hip implantsLZO · Traditional | Medacta International S.A. | 09/19/2025SE |
| K243021 | Longboard Revision Hip StemLZO · Traditional | Signature Orthopaedics Pty, Ltd. | 08/07/2025SE |
| K251906 | Z1 Hip SystemLZO · Special | Zimmer, Inc. | 07/18/2025SE |
More from Zimmer, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K991538 | Opera Cupflanged Acetabular ComponentsJDI · Abbreviated | 06/03/1999SE |
| K970635 | Titanium Spinal Rod SystemKWQ · Traditional | 08/14/1997SE |
| K970748 | Taylor Spatial Frame External Fixation SystemKTT · Traditional | 05/09/1997SE |
| K970751 | Heidelberg External FixatorJDW · Traditional | 04/16/1997SE |
| K970713 | Compass Universal HingeJDW · Traditional | 04/03/1997SE |
| K970351 | Global Taper Spectron Hip StemsJDI · Traditional | 02/28/1997SE |
| K970337 | Ha Global Taper (GT) Tapered Hip StemMEH · Traditional | 02/28/1997SE |
| K963255 | Profix Plus Tibial Insert, Profix PS Plus Tibial Insert, Profix P/S Tibial InsertJWH · Traditional | 01/02/1997SN |
| K962784 | Ultium Spinal Plating SystemMNH · Traditional | 10/02/1996SN |
Questions and answers
When was Zirconia Prozyr Ceramic 12/14 Global Taper (GT) Femoral Heads cleared by the FDA?
Zirconia Prozyr Ceramic 12/14 Global Taper (GT) Femoral Heads (K971414) received a 510(k) decision of Substantially Equivalent on July 16, 1997, 91 days after the submission was received.
What is the product code of K971414?
The FDA product code is LZO – Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3353.