Proform Hip System
FDA 510(k) K934161 · Stelkast Company
510(k) numberK934161
Submission
- Device name
- Proform Hip System
- Applicant
- Stelkast Company
Pittsburgh, PA, US - Received
- August 27, 1993
- Decision date
- March 10, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDO – Device, Fixation, Proximal Femoral, Implant
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230764 | OsteoCentric Integrated Hip Fastener SystemJDO · Special | OsteoCentric Technologies | 04/18/2023SE |
| K213126 | Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP…JDO · Traditional | Smith & Nephew, Inc. | 09/29/2022SE |
| K210247 | OsteoCentric Integrated Hip Fastener SystemJDO · Traditional | Osteocentric Technologies D.B.A. Osteocentric… | 04/30/2021SE |
| K193029 | Conquest FNJDO · Traditional | Smith & Nephew, Inc. | 02/28/2020SE |
| K173826 | THP Hip Fracture Plating SystemJDO · Traditional | Biomet, Inc. | 02/07/2018SE |
| K172785 | Conquest FNJDO · Special | Smith & Nephew | 12/22/2017SE |
| K152686 | Conquest FNJDO · Traditional | Smith & Nephew | 03/17/2016SE |
| K140018 | TSP Hip Fracture Plating SystemJDO · Traditional | Biomet, Inc. | 04/04/2014SE |
| K080685 | Hiploc Compression Hip ScrewJDO · Traditional | Biomet Manufacturing, Inc. | 08/15/2008SE |
| K080434 | Intertan CHS Locking Plate System Prox Fem Plates/ScrewJDO · Traditional | Smith & Nephew, Inc. | 04/10/2008SE |
More from Smith & Nephew, 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 |
| K094035 | Exp Acetabular Liner, Models SC3342 Non-Hooded 28MM, SC3343 Hooded 28MMOQG · Traditional | 03/24/2011SE |
| 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 |
Questions and answers
When was Proform Hip System cleared by the FDA?
Proform Hip System (K934161) received a 510(k) decision of Substantially Equivalent on March 10, 1994, 195 days after the submission was received.
What is the product code of K934161?
The FDA product code is JDO – Device, Fixation, Proximal Femoral, Implant, a Class II (moderate risk) device regulated under 21 CFR 888.3030.