Proform Ha Hip System
FDA 510(k) K934162 · Stelkast Company
510(k) numberK934162
Submission
- Device name
- Proform Ha Hip System
- Applicant
- Stelkast Company
Pittsburgh, PA, US - Received
- August 27, 1993
- Decision date
- March 9, 1994
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
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 Ha Hip System cleared by the FDA?
Proform Ha Hip System (K934162) received a 510(k) decision of Substantially Equivalent for Some Indications on March 9, 1994, 194 days after the submission was received.
What is the product code of K934162?
The FDA product code is JDO – Device, Fixation, Proximal Femoral, Implant, a Class II (moderate risk) device regulated under 21 CFR 888.3030.