510(k) · Cleared
ClearedDepuy Universal Gription TF Cones
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Cleared on Sep 29, 2010 as substantially equivalent to K053340 (Zimmer Trabecular, 2006) and 4 other predicates after a 225-day review. Its family tree reaches back 4 generations to 1998. 53 later devices descend from it.
- Decided
- Sep 29, 2010
- Review
- 225 days
- Class
- Class II
- Product code
- JWH
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K982302 (1998). 13 ancestors in all. 53 later devices descend from it, 5 citing it directly.
- Root · 4 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 3 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 2 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 1 generation backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
- This deviceK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
- Descendant · cites it directly · 40 of its ownK143393 Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · Recalled
- Descendant · 2 generations on · 24 of its ownK172326 Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee…Stryker Orthopaedics · 2017 · Recalled
- Descendant · 3 generations on · 14 of its ownK173849 Triathlon Total Knee SystemStryker Orthopaedics · 2018 · Recalled
- Descendant · 3 generations on · 11 of its ownK190402 Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019
- Descendant · 2 generations on · 8 of its ownK153595 Optetrak Logic Metaphyseal ConesExactech, Inc. · 2016
Showing 5 of 53 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 53 · See all- K143393Triathlon Tritanium Cone AugmentsStryker Orthopaedics · 2015 · cites it directly40descendants
- K172326Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee SystemStryker Orthopaedics · 2017 · 2 generations on24descendants
- K173849Triathlon Total Knee SystemStryker Orthopaedics · 2018 · 3 generations on14descendants
- K190402Triathlon Total Knee System-Additional ComponentsStryker Orthopaedics (Aka Howmedica Osteonics Corp.) · 2019 · 3 generations on11descendants
- K153595Optetrak Logic Metaphyseal ConesExactech, Inc. · 2016 · 2 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −3 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −2 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −1 | K053340 | Trabecular Metal Tibial and Femoral Cone Augments | Zimmer Trabecular | 2006 | — |
| 0 (this device) | K100391 | Depuy Universal Gription TF Cones | DePuy Orthopaedics, Inc. | 2010 | — |
| +1 | K143393 | Triathlon Tritanium Cone Augments | Stryker Orthopaedics | 2015 | 1 |
| +2 | K172326 | Triathlon Total Knee System, Triathlon PKR System, Restoris MCK Knee System | Stryker Orthopaedics | 2017 | 1 |
| +3 | K173849 | Triathlon Total Knee System | Stryker Orthopaedics | 2018 | 3 |
| +3 | K190402 | Triathlon Total Knee System-Additional Components | Stryker Orthopaedics (Aka Howmedica Osteonics Corp.) | 2019 | — |
| +2 | K153595 | Optetrak Logic Metaphyseal Cones | Exactech, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 8 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 8 | 0 |
| 2025 | 12 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JWH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JWH device
- #1 K221479 Persona Personalized Knee Systemscore 22.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K053340 | Trabecular Metal Tibial and Femoral Cone AugmentsSummary page 2…: Trabecular Metal Tm Tibial Cone Augments and Trabecular MetalTm Femoral Cone Augments, K053340 Trabecular MetalTm Metal Femoral Cone Augments, K05 1756… | 2006 |
| * | K051756 | Modification to:Trabecular Metal Femoral Cone Augments, Models 03-125-ZZZZSummary page 2…r MetalTm Femoral Cone Augments, K053340 Trabecular MetalTm Metal Femoral Cone Augments, K05 1756 HIP Trabecular Metaltm Acetabular Augments, K0… | 2005 |
| * | K061067 | Trabecular Metal Acetabular AugmentsSummary page 2…Augments, K05 1756 HIP Trabecular Metaltm Acetabular Augments, K06 1067 T Acetabular Augments, Trabecular Metal"… | 2006 |
| * | K042871 | Trabecular Metal Acetabular Augments, Models 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3…Summary page 2…K06 1067 T Acetabular Augments, Trabecular Metal" K042871 Biomet Porous Titanium Acetabular Augments, K052888 DEVICE… | 2004 |
| * | K052888 | Porous Titanium Acetabular AugmentsSummary page 2…Trabecular Metal" K042871 Biomet Porous Titanium Acetabular Augments, K052888 DEVICE DESCRIPTION: KNEE The DePuy Universal Gription TF Cone component is manufactured from Commercially Pure (… | 2005 |
What descends from it? (53)
See all 535 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143393 | Triathlon Tritanium Cone Augments | 2015 | 40 |
| K123924 | Depuy Gription TF 5.5MM Sterile Locking Screws | 2013 | 7 |
| K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | 2024 | 5 |
| K171966 | Mpact® 3D Metal™ Implants and Augments 3D Metal™ | 2018 | 3 |
| K212746 | ATTUNE Revision Cones | 2022 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 4.5 years on median.
- 5 of the 13 ancestors have a recall of any class.
- Of its descendants, K143393 (Stryker Orthopaedics, 2015) has gone furthest, with 40 descendants of its own.
- 8 other devices also cite its predicate K053340.
How does its category compare?
All JWH devicesJWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JWH
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JWH
55in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JWH
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JWH
9,306in 2025
MAUDE reports naming product code JWH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 18 | 74 | 14 | 1,305 |
| 2008 | 17 | 81 | 10 | 1,483 |
| 2009 | 11 | 168 | 109 | 1,870 |
| 2010 | 19 | 85 | 32 | 3,286 |
| 2011 | 25 | 87 | 27 | 5,133 |
| 2012 | 33 | 85 | 85 | 5,203 |
| 2013 | 31 | 128 | 31 | 6,135 |
| 2014 | 33 | 98 | 13 | 6,722 |
| 2015 | 27 | 87 | 11 | 6,881 |
| 2016 | 18 | 88 | 17 | 7,586 |
| 2017 | 25 | 118 | 61 | 12,263 |
| 2018 | 25 | 90 | 14 | 14,071 |
| 2019 | 28 | 133 | 5 | 14,987 |
| 2020 | 22 | 59 | 2 | 12,592 |
| 2021 | 24 | 61 | 8 | 9,408 |
| 2022 | 17 | 56 | 12 | 8,364 |
| 2023 | 20 | 57 | 67 | 8,947 |
| 2024 | 19 | 89 | 7 | 10,828 |
| 2025 | 20 | 55 | 2 | 9,306 |
| 2026 | 12 | 63 | 4 | — |
What is it indicated for?
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…
Read the full statement (277 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100391 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100391: Depuy Universal Gription TF Cones.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100391
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026