510(k) · Cleared
Recalled · 2007Depuy AE TK2 Hip Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Cleared on Oct 9, 1997 as substantially equivalent to K791619 (Synthes (Usa), 1979) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1979. 42 later devices descend from it. It has been recalled 2 times.
- Decided
- Oct 9, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- KTT
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 1 generation to K791619 (1979). 2 ancestors in all. 42 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK791619 Dynamic Hip ScrewSynthes (Usa) · 1979
- This deviceK972629 Depuy AE TK2 Hip Screw SystemDepuy, Inc. · 1997
- Descendant · cites it directly · 32 of its ownK031401 Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003
- Descendant · 2 generations on · 31 of its ownK091425 Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010
- Descendant · 3 generations on · 29 of its ownK100497 Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010
- Descendant · 3 generations on · 16 of its ownK102369 Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · Recalled
- Descendant · 3 generations on · 15 of its ownK111056 Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · Recalled
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 42 · See all- K031401Fixion Dynamic Hip Screw System (Fixion DHS)Disco-O-Tech Medical Technologies, Ltd. · 2003 · cites it directly32descendants
- K091425Quantum M Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2010 · 2 generations on31descendants
- K100497Quantum IM Composite Nailing System (Quantum Nailing System)N.M.B. Medical Applications, Ltd. · 2010 · 3 generations on29descendants
- K102369Piccolo Composite Nailing SystemN.M.B. Medical Applications, Ltd. · 2011 · 3 generations on16descendants
- K111056Piccolo Composite Nailing SystemCarboFix Orthopedics, Ltd. · 2011 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K791619 | Dynamic Hip Screw | Synthes (Usa) | 1979 | — |
| 0 (this device) | K972629 | Depuy AE TK2 Hip Screw System | Depuy, Inc. | 1997 | — |
| +1 | K031401 | Fixion Dynamic Hip Screw System (Fixion DHS) | Disco-O-Tech Medical Technologies, Ltd. | 2003 | — |
| +2 | K091425 | Quantum M Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2010 | — |
| +3 | K100497 | Quantum IM Composite Nailing System (Quantum Nailing System) | N.M.B. Medical Applications, Ltd. | 2010 | — |
| +3 | K102369 | Piccolo Composite Nailing System | N.M.B. Medical Applications, Ltd. | 2011 | 1 |
| +3 | K111056 | Piccolo Composite Nailing System | CarboFix Orthopedics, Ltd. | 2011 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 2 | 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 KTT? 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 KTT device
- #1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K791619 | Dynamic Hip ScrewSummary page 1…lag screws will be offered in a super and standard thread form. The DePuy ACE TK2 Hip Screw System is similar in design to the Synthes Dynamic Hip System (510k approval K791619) and the DePuy ACE Select Lock Hip Screw System (regulatory assessment approval based on K861178 released 4/15/86), which are ind… | 1979 |
| * | K861178 | Depuy Compression Hip Screw SystemSummary page 1…em is similar in design to the Synthes Dynamic Hip System (510k approval K791619) and the DePuy ACE Select Lock Hip Screw System (regulatory assessment approval based on K861178 released 4/15/86), which are indicated for fractures of the proximal femur extending from the subcapital area to the level of the… | 1986 |
What descends from it? (42)
See all 424 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 30, 2007 | Not classified | Z-0434-2008 | Process control | Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel. |
| Oct 30, 2007 | Not classified | Z-0435-2008 | Process control | Mis-etched/labeled as to barrel length: the lot with the short barrel was etched and labeled as a standard barrel and the lot with the standard barrel was etched and labeled as a short barrel. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KTT devicesKTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KTT
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KTT
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KTT
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KTT
673in 2025
MAUDE reports naming product code KTT, 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 | 55 | 2 | 45 |
| 2008 | 11 | 73 | 1 | 66 |
| 2009 | 11 | 94 | 2 | 45 |
| 2010 | 12 | 148 | 1 | 121 |
| 2011 | 10 | 157 | 0 | 196 |
| 2012 | 9 | 140 | 4 | 527 |
| 2013 | 7 | 87 | 7 | 898 |
| 2014 | 14 | 129 | 0 | 445 |
| 2015 | 12 | 60 | 0 | 401 |
| 2016 | 10 | 142 | 0 | 400 |
| 2017 | 11 | 184 | 1 | 485 |
| 2018 | 6 | 149 | 14 | 597 |
| 2019 | 8 | 110 | 3 | 800 |
| 2020 | 9 | 200 | 0 | 942 |
| 2021 | 10 | 83 | 2 | 961 |
| 2022 | 3 | 25 | 0 | 627 |
| 2023 | 7 | 29 | 0 | 554 |
| 2024 | 5 | 90 | 0 | 523 |
| 2025 | 10 | 88 | 0 | 673 |
| 2026 | 5 | 68 | 11 | — |
What is it indicated for?
The DePuy ACE TK2 Hip Screw System is indicated for fractures of the proximal femur extending from the subcapital area to the level of the lesser trochanter, as well as proximal femoral osteotomies. Appropriate utilization of this device ultimately depends on the surgical judgement surrounding each patient’s particular situation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972629: Depuy AE TK2 Hip Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972629
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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