510(k) · Cleared
ClearedDepuy Gription TF 5.5MM Sterile Locking Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Orthopaedics · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Mar 1, 2013 as substantially equivalent to K100391 (DePuy Orthopaedics, Inc., 2010) after a 71-day review. Its family tree reaches back 5 generations to 1998. 7 later devices descend from it.
- Decided
- Mar 1, 2013
- Review
- 71 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K982302 (1998). 14 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK982302 Implex Continuum Knee - Hedrocel Tibial SpacersImplex Corp. · 1998
- 4 generations backK024161 Nexgen Complete Knee Solution - Trabecular Metal AugmentsImplex Corp. · 2003 · Recalled
- 3 generations backK040487 Trabecular Metal Knee System AugmentsImplex Corp. · 2004 · Recalled
- 2 generations backK053340 Trabecular Metal Tibial and Femoral Cone AugmentsZimmer Trabecular · 2006
- 1 generation backK100391 Depuy Universal Gription TF ConesDePuy Orthopaedics, Inc. · 2010
- This deviceK123924 Depuy Gription TF 5.5MM Sterile Locking ScrewsDepuy Orthopaedics · 2013
- Descendant · cites it directly · 5 of its ownK231873 DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT…Depuy Ireland UC · 2024
- Descendant · 2 generations on · 1 of its ownK251292 RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025
- Descendant · 2 generations on · 1 of its ownK243977 EMPHASYS Acetabular SystemDepuy Ireland UC · 2025
- Descendant · 3 generations on · 0 of its ownK260173 M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026
- Descendant · 3 generations on · 0 of its ownK252067 Velora Acetabular SystemRestor3D, Inc. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K231873DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip…Depuy Ireland UC · 2024 · cites it directly5descendants
- K251292RECLAIM Monobloc Revision Femoral StemDepuy Ireland UC · 2025 · 2 generations on1descendant
- K243977EMPHASYS Acetabular SystemDepuy Ireland UC · 2025 · 2 generations on1descendant
- K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A. · 2026 · 3 generations on0descendants
- K252067Velora Acetabular SystemRestor3D, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K982302 | Implex Continuum Knee - Hedrocel Tibial Spacers | Implex Corp. | 1998 | — |
| −4 | K024161 | Nexgen Complete Knee Solution - Trabecular Metal Augments | Implex Corp. | 2003 | 2 |
| −3 | K040487 | Trabecular Metal Knee System Augments | Implex Corp. | 2004 | 1 |
| −2 | K053340 | Trabecular Metal Tibial and Femoral Cone Augments | Zimmer Trabecular | 2006 | — |
| −1 | K100391 | Depuy Universal Gription TF Cones | DePuy Orthopaedics, Inc. | 2010 | — |
| 0 (this device) | K123924 | Depuy Gription TF 5.5MM Sterile Locking Screws | Depuy Orthopaedics | 2013 | — |
| +1 | K231873 | DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip… | Depuy Ireland UC | 2024 | — |
| +2 | K251292 | RECLAIM Monobloc Revision Femoral Stem | Depuy Ireland UC | 2025 | — |
| +2 | K243977 | EMPHASYS Acetabular System | Depuy Ireland UC | 2025 | — |
| +3 | K260173 | M-Vizion Femoral Revision System Extension | Medacta International S.A. | 2026 | — |
| +3 | K252067 | Velora Acetabular System | Restor3D, Inc. | 2025 | — |
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 |
|---|---|---|
| 2024 | 2 | 0 |
| 2025 | 4 | 0 |
| 2026 | 1 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K100391 | Depuy Universal Gription TF ConesSummary page 2…ile Screws Characteristic Screws Locking [Comparable Screws] (K100391) Material TI-6AL-4 V-ELI TI-6AL-4 V-ELI Head geometry .Locking… | 2010 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 14 ancestors have a recall of any class.
- Of its descendants, K231873 (Depuy Ireland UC, 2024) has gone furthest, with 5 descendants of its own.
- 4 other devices also cite its predicate K100391.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
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.…
Read the full statement (191 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123924 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123924: Depuy Gription TF 5.5MM Sterile Locking Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123924
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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