# K123924: Depuy Gription TF 5.5MM Sterile Locking Screws

- Pathway: 510(k) (Traditional)
- Applicant: Depuy Orthopaedics
- Decided: Mar 1, 2013 after 71 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K982302 (1998). 14 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100391: Depuy Universal Gription TF Cones, DePuy Orthopaedics, Inc. (2010) Summary page 2.

## Most influential descendants
- K231873: DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional (2024), 5 descendants of its own
- K251292: RECLAIM Monobloc Revision Femoral Stem (2025), 1 descendant of its own
- K243977: EMPHASYS Acetabular System (2025), 1 descendant of its own
- K260173: M-Vizion Femoral Revision System Extension (2026), 0 descendants of its own
- K252067: Velora Acetabular System (2025), 0 descendants of its own

## Indications for use
The DePuy Gription TF Acetabular Augments, Buttresses and Shims are indicated for use with the Pinnacle®9 Acetabular cup System, the Pinnacle® Bantam Acetabular Cup System and the Pinnacle®t Revision Acetabular Cup System for total hip replacement in the following conditions: 1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. Avascular necrosis of the femoral head. 3. Acute traumatic fracture of the femoral head or neck. 4. Failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemniarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. Certain cases of ankylosis. The porous Gription TF titanium acetabular augment is affixed to the mating acetabular cup using bone cement or mechanical screw fixation. Thle assembled augment/acetabular cup construct is intended for cemented or cementless use. The porous Gription TF titanium shim is affixed to the mating buttress using bone cement. This porous Gription TF titanium buttress is affixed to the mating acetabular cup using bone cement. The Gription TF titanium buttress/shim is affixed to the bone using bone cement or mechanical screw fixation. The assembled buttress/acetabular cup construct is intended for cemented or cementless use.

Source page: https://510kreport.com/device/K123924
Methodology: https://510kreport.com/methodology