Ath Metal:Uhmwpe Total Hip System
FDA 510(k) K882675 · Kinamed, Inc.
510(k) numberK882675
Submission
- Device name
- Ath Metal:Uhmwpe Total Hip System
- Applicant
- Kinamed, Inc.
Los Angeles, CA, US - Received
- June 28, 1988
- Decision date
- August 19, 1988
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 |
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| K030256 | Iso-Elastic Cerclage SystemJDQ · Traditional | 10/21/2003SE |
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Questions and answers
When was Ath Metal:Uhmwpe Total Hip System cleared by the FDA?
Ath Metal:Uhmwpe Total Hip System (K882675) received a 510(k) decision of Substantially Equivalent for Some Indications on August 19, 1988, 52 days after the submission was received.
What is the product code of K882675?
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.