Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM
FDA 510(k) K094035 · Stelkast Company
Submission
- Device name
- Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM
- Applicant
- Stelkast Company
Mcmurray, PA, US - Received
- December 30, 2009
- Decision date
- March 24, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OQG – Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3358
- Specialty
- Orthopedic
- Implant
- Yes
1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Correction of functional deformity. 4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. 5. Revision procedures where other treatment or devices have failed. Cemented and…
Other 510(k)s with product code OQG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K202705 | Prime and DYNASTY® Additive Manufacturing ShellsOQG · Traditional | Microport Orthopedics, Inc. | 08/20/2021SE |
| K203472 | KMTI Hip Replacement SystemOQG · Special | Kyocera Medical Technologies, Inc. | 04/02/2021SE |
| K201660 | KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell…OQG · Special | Kyocera Medical Technologies, Inc. | 07/16/2020SE |
| K200328 | Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup SystemOQG · Special | Kyocera Medical Technologies, Inc. | 03/11/2020SE |
| K172651 | FMP Extended LinersOQG · Traditional | Encore Medical L.P. | 12/13/2017SE |
| K171543 | Renovis Surgical Hip Replacement SystemOQG · Traditional | Renovis Surgical Technologies | 11/16/2017SE |
| K173104 | Klassic HD® Hooded Acetabular Insert with E-Link® Poly, Klassic HD® Low Profile…OQG · Special | Total Joint Orthopedics, Inc. | 10/27/2017SE |
| K143647 | Renovis Surgical Hip Replacement SystemOQG · Traditional | Renovis Surgical Technologies, Inc. | 05/11/2015SE |
| K140130 | X-Alt Highly Cross Linked Acetabular Liners with Vitamin E, Neutral, 10 Degree Hooded…OQG · Traditional | Encore Medical L.P. | 11/06/2014SE |
| K141972 | Klassic HD Acetabular Insert with E-Link PolyOQG · Traditional | Total Joint Orthopedics, Inc. | 10/09/2014SE |
More from Total Joint Orthopedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K190276 | Provident II Hip StemLPH · Special | 03/08/2019SE |
| K173875 | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial InsertJWH · Special | 01/19/2018SE |
| K162222 | GENflex2 Total Knee SystemJWH · Special | 09/07/2016SE |
| K122883 | Exp Tibial Inserts and Patellar Components for the Proven Gen-Flex Total Knee SystemJWH · Traditional | 08/05/2013SE |
| K122773 | Cross-Over Acetabular Shell & LinerOQG · Special | 10/09/2012SE |
| K081458 | Proven Stem ExtenderJWH · Special | 06/06/2008SE |
| K063211 | Proven Knee System High Flexion Tibial InsertJWH · Traditional | 01/18/2007SE |
| K051976 | Proven Revision Modular Tibial TrayJWH · Traditional | 10/17/2005SE |
| K033944 | Stelkast 32MM Modular Ceramic Femoral HeadLZO · Traditional | 03/12/2004SE |
| K032824 | Stelkast Unicondylar Knee SystemHSX · Traditional | 11/13/2003SE |
Questions and answers
When was Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM cleared by the FDA?
Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MM (K094035) received a 510(k) decision of Substantially Equivalent on March 24, 2011, 449 days after the submission was received.
What is the product code of K094035?
The FDA product code is OQG – Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3358.