Premier-Total Hip
FDA 510(k) K894051 · Intermedics Orthopedics
510(k) numberK894051
Submission
- Device name
- Premier-Total Hip
- Applicant
- Intermedics Orthopedics
Austin, TX, US - Received
- June 7, 1989
- Decision date
- August 28, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120595 | Unisyn Plus Hip StemLWJ · Traditional | Consensus Orthopedics, Inc. | 10/12/2012SE |
| K103518 | Trinity Acetabular SystemLWJ · Traditional | Corin USA | 03/09/2011SE |
| K090764 | Novation CFS Press-Fit and Cemented StemsLWJ · Special | Exactech, Inc. | 04/21/2009SE |
| K082146 | Metha Short Stem Hip System XL Femoral HeadLWJ · Special | Aesculap Implant Systems, Inc. | 09/09/2008SE |
| K070061 | 36MM Cocr Femoral Head and 36MM Acetabular InsertLWJ · Special | Hayes Medical, Inc. | 01/31/2007SE |
| K062978 | U2 Hip Stem, Ti Plasma SprayLWJ · Traditional | United Orthopedic Corp. | 01/16/2007SE |
| K062383 | Unisyn Ha Plasma Modular HipLWJ · Special | Hayes Medical, Inc. | 12/21/2006SE |
| K061699 | ExciaLWJ · Special | Aesculap, Inc. | 08/18/2006SE |
| K051826 | Betacone Hip Prosthesis SystemLWJ · Traditional | Waldemar Link GmbH & Co. KG | 11/18/2005SE |
| K050262 | U2 Acetabular ComponentLWJ · Traditional | United Orthopedic Corp. | 08/15/2005SE |
More from United Orthopedic Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K970300 | Natural-Hip System Porous Stem with Ha/CstiLPH · Traditional | 07/03/1997SE |
| K970498 | Natural-Knee II Revision Femoral Spacer LugsJWH · Traditional | 04/30/1997SE |
| K970166 | Natural-Hip System Cocr Revision StemLZO · Traditional | 04/08/1997SE |
| K970567 | Select Shoulder Curved-Back Pegged All Poly GlenoidsKWT · Traditional | 02/27/1997SE |
| K964357 | Natural-Hip System Cocr StemLZO · Traditional | 01/27/1997SE |
| K964350 | Modula Options for Severe Bone Loss and TraumaJDI · Traditional | 01/16/1997SE |
| K962190 | Patellofemoral Joint ProsthesisKRR · Traditional | 10/28/1996SE |
| K963266 | Natural Hip System Porous Stem - Collarless, CollaredLPH · Traditional | 10/15/1996SE |
| K963155 | Intermoore Fracture Hip Stem (Modify)LWJ · Traditional | 10/01/1996SE |
| K962315 | Select Shoulder Cocr Humeral Stem ComponentKWT · Traditional | 09/03/1996SE |
Questions and answers
When was Premier-Total Hip cleared by the FDA?
Premier-Total Hip (K894051) received a 510(k) decision of Substantially Equivalent on August 28, 1989, 82 days after the submission was received.
What is the product code of K894051?
The FDA product code is LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3360.