510(k) · Cleared
ClearedDepuy Ace Ring Skull Pins-Mri, Depuy Ace Spring Loaded Tong Pin-Mri, Depuy Ace Fixed Tip Tong Pin-Mri
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Depuy Ace Medical Co. · LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Cleared on May 22, 1998 as substantially equivalent to K810193 (Ace Orthopedic Manufacturing Co., 1981) after a 191-day review. Its family tree reaches back 1 generation to 1981.
- Decided
- May 22, 1998
- Review
- 191 days
- Class
- Class II
- Product code
- LXT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K810193 (1981). No later device cites it as a predicate yet.
- Root · 1 generation backK810193 Trippi-Wells Dual Purpose Universal TongAce Orthopedic Manufacturing Co. · 1981
- This deviceK974245 Depuy Ace Ring Skull Pins-Mri, Depuy Ace Spring Loaded Tong Pin-Mri…Depuy Ace Medical Co. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K810193 | Trippi-Wells Dual Purpose Universal Tong | Ace Orthopedic Manufacturing Co. | 1981 | — |
| 0 (this device) | K974245 | Depuy Ace Ring Skull Pins-Mri, Depuy Ace Spring Loaded Tong Pin-Mri, Depuy Ace… | Depuy Ace Medical Co. | 1998 | — |
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 LXT? 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 LXT device
- #1 K230067 Para-Fix External Fixation Systemscore 6.3 · 2 generations · no Class I recall
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K810193 | Trippi-Wells Dual Purpose Universal TongSummary page 1…ACE Fixed Tip Tong Pin — MRI are similar in design and indications for use to the DePuy ACE Spring Loaded (Trippi- Wells) Skull Pin, which received approval under 510(k) K810193A. Based on the above information, DePuy ACE Medical Company firmly believes that the new skull pins are substantially equivalent… | 1981 |
| * | — | DePuy ACE Standard Skull Pin Named without a submission number | |
| * | — | DePuy ACE Fixed Tip Tong Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
How does its category compare?
All LXT devicesLXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LXT
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · LXT
Too few LXT 510(k)s in any year since 2007 to give a median.
Recalls per year · LXT
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LXT
7in 2025
MAUDE reports naming product code LXT, 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 | 1 | — | 1 | 26 |
| 2008 | 1 | — | 0 | 58 |
| 2009 | 1 | — | 7 | 41 |
| 2010 | 0 | — | 0 | 33 |
| 2011 | 1 | — | 0 | 85 |
| 2012 | 0 | — | 0 | 42 |
| 2013 | 2 | — | 0 | 39 |
| 2014 | 0 | — | 0 | 36 |
| 2015 | 0 | — | 0 | 35 |
| 2016 | 0 | — | 0 | 38 |
| 2017 | 0 | — | 0 | 66 |
| 2018 | 0 | — | 2 | 73 |
| 2019 | 0 | — | 0 | 40 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 0 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 21 |
| 2023 | 1 | — | 0 | 18 |
| 2024 | 0 | — | 0 | 27 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Pins, when used in conjunction with the DePuy ACE Trippi-Wells Tong, DePuy ACE Standard Tong, DePuy ACE Universal Tong, or Open and Closed Back Halo Rings, may be used for stabilization of the cervical spine in stationary and mobile traction following:
Cervical fractures
* Ligamentous injury of the cervical spine
» Fusion or other surgery of the cervical spine
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/K974245 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974245: Depuy Ace Ring Skull Pins-Mri, Depuy Ace Spring Loaded Tong Pin-Mri, Depuy Ace Fixed Tip Tong Pin-Mri.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974245
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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