510(k) Report

510(k) · Cleared

Cleared

Trippi-Wells Dual Purpose Universal Tong

K810193510(k) TraditionalCleared Mar 20, 198156-day reviewClass II21 CFR 882.5960

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ace Orthopedic Manufacturing Co. · HAX Tong, Skull For Traction

Cleared on Mar 20, 1981 after a 56-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided
Mar 20, 1981
Review
56 days
Class
Class II
Product code
HAX
Recalls
None
Predicates
0

1 later device descends from it, 1 citing it directly.

Descendants, by year cleared 1998: 1 descendant cleared19801990200020102020
  1. This deviceK810193 Trippi-Wells Dual Purpose Universal TongAce Orthopedic Manufacturing Co. · 1981
  2. Descendant · cites it directly · 0 of its ownK974245 Depuy Ace Ring Skull Pins-Mri, Depuy Ace Spring Loaded Tong Pin-Mri…Depuy Ace Medical Co. · 1998

Most influential descendants

Showing 1 of 1 · See all
  • K974245Depuy Ace Ring Skull Pins-Mri, Depuy Ace Spring Loaded Tong Pin-Mri, Depuy Ace Fixed Tip…Depuy Ace Medical Co. · 1998 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K810193Trippi-Wells Dual Purpose Universal TongAce Orthopedic Manufacturing Co.1981—
+1K974245Depuy Ace Ring Skull Pins-Mri, Depuy Ace Spring Loaded Tong Pin-Mri, Depuy Ace…Depuy Ace Medical Co.1998—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K810193, 1981–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HAX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K974245Depuy Ace Ring Skull Pins-Mri, Depuy Ace Spring Loaded Tong Pin-Mri, Depuy Ace Fixed Tip…Depuy Ace Medical Co.19980

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?

  • Of its descendants, K974245 (Depuy Ace Medical Co., 1998) has gone furthest, with 0 descendants of its own.

How does its category compare?

All HAX devices

HAX Tong, Skull For Traction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HAX

1in 2009

2007: 12009: 1
2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HAX

Too few HAX 510(k)s in any year since 2007 to give a median.

Recalls per year · HAX

4in 2018

2008: 32014: 62018: 4
2007high 6 (2014) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HAX

1in 2020

2008: 12010: 12011: 22015: 12016: 12017: 12020: 1
2007high 2 (2011) · low 0 (2007)2025

MAUDE reports naming product code HAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—31
20091—00
20100—01
20110—02
20120—00
20130—00
20140—60
20150—01
20160—01
20170—01
20180—40
20190—00
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Ace Orthopedic Manufacturing Co.

14 FDA decisions under this applicant name. See the company

  • K934962Aim Supracondylar NailAce Orthopedic Manufacturing Co. · 1994
  • K934643Ace Humeral NailAce Orthopedic Manufacturing Co. · 1994
  • K936045Ace Unilateral Fixator IIAce Orthopedic Manufacturing Co. · 1994
  • K926047Ace 8.0MM Cannulated Cancellous Bone ScrewAce Orthopedic Manufacturing Co. · 1993
  • K920738Ace 100 Degrees Tubular PlateAce Orthopedic Manufacturing Co. · 1992

Recent decisions in HAX

The HAX category page

  • K090733PMT Halo SystemPmt Corp. · 2009
  • K071173Resolve Tongs, Small/Medium, Resolve Tongs, Medium/Large, Model JT-200D, JT-100DOssur Americans (Formerly the Jerome Group) · 2007
  • K051918Resolve Open Back Halo RingsJerome Medical · 20057 recalls
  • K023959Jerome Glass RingThe Jerome Group, Inc. · 20036 recalls
  • K003662Spine Works CollarSpine Works · 2001

https://510kreport.com/device/K810193 · printed Nov 6, 2026

Cite this page

510(k) Report. “K810193: Trippi-Wells Dual Purpose Universal Tong.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810193

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026