# K100391: Depuy Universal Gription TF Cones

- Pathway: 510(k) (Traditional)
- Applicant: DePuy Orthopaedics, Inc.
- Decided: Sep 29, 2010 after 225 days
- Product code: JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer)
- Device class: 2
- Regulation: 21 CFR 888.3560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K982302 (1998). 13 ancestors in all.
53 later devices descend from it; 5 cite it directly.
0 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053340: Trabecular Metal Tibial and Femoral Cone Augments, Zimmer Trabecular (2006) Summary page 2.
- K051756: Modification to:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZ, Zimmer Trabecular (2005) Summary page 2.
- K061067: Trabecular Metal Acetabular Augments, Zimmer Trabecular (2006) Summary page 2.
- K042871: Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3, Zimmer Trabecular (2004) Summary page 2.
- K052888: Porous Titanium Acetabular Augments, Biomet Manufacturing Corp (2005) Summary page 2.

## Most influential descendants
- K143393: Triathlon Tritanium Cone Augments (2015), 40 descendants of its own
- K172326: Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System (2017), 24 descendants of its own
- K173849: Triathlon Total Knee System (2018), 14 descendants of its own
- K190402: Triathlon Total Knee System-Additional Components (2019), 11 descendants of its own
- K153595: Optetrak Logic Metaphyseal Cones (2016), 8 descendants of its own

## Indications for use
The DePuy Universal Gription™ TF Cones are intended for use with the P.F.C.® Modular Knee, P.E.C.® Sigma® Knee, Sigma® TC3 Revision Knee, and S-ROM® Tibial Tray in total knee replacement surgery for patients suffering from severe pain and disability due to permanent structural damage resulting from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, pseudogout, trauma or failed prior surgical intervention. The porous Gription TF titanium cone is affixed to the mating tibial or femoral component using bone cement. After attachment, the cones are intended for fixation as an assembled construct into either the proximal tibia or distal femur, with or without bone cement. The DePuy Gription TF Acetabular Augments, Buttresses and Shims are indicated for use with the Pinnacle® Acetabular Cup System, the Pinnacle® Bantam Acetabular Cup System and the Pinnacle® 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, hemiarthroplasty, 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. The 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 assembled buttress/acetabular cup construct is intended for cemented or cementless use.

Source page: https://510kreport.com/device/K100391
Methodology: https://510kreport.com/methodology