510(k) Report

510(k) · Cleared

Cleared

Resolve Tongs, Small/Medium, Resolve Tongs, Medium/Large, Model JT-200D, JT-100D

K071173510(k) SpecialCleared May 25, 200728-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

Ossur Americans (Formerly the Jerome Group) · HAX Tong, Skull For Traction

Cleared on May 25, 2007 as substantially equivalent to K930021 (Jerome Medical, 1995) after a 28-day review. Its family tree reaches back 1 generation to 1995.

Decided
May 25, 2007
Review
28 days
Class
Class II
Product code
HAX
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K930021 (1995). No later device cites it as a predicate yet.

Reference device: K051918 · Resolve Open Back Halo Rings · Jerome Medical · 2005 · recalledK930021 · J Tongs · Jerome Medical · 19951996199820002002200420062008
K930021 · J Tongs · Jerome Medical · 19950
  1. Root · 1 generation backK930021 J TongsJerome Medical · 1995
  2. This deviceK071173 Resolve Tongs, Small/Medium, Resolve Tongs, Medium/Large, Model…Ossur Americans (Formerly the Jerome Group) · 2007
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K930021J TongsJerome Medical1995—
0 (this device)K071173Resolve Tongs, Small/Medium, Resolve Tongs, Medium/Large, Model JT-200D, JT-100DOssur Americans (Formerly the Jerome Group)2007—
FIG. 1 — Lineage of K071173, 1995–2007Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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.

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  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K930021J Tongs
Summary page 1
…Name: Traction Tongs Classification Name: Tong, Skull for Traction, Sec. 882.5960, Neurological Devices, Class II,HAX Substantially Equivalent To: JTongs Traction Tongs (K930021) manufactured by Jerome Medical. Also similar to the ReSolve Open Back Halo Ring (KO51918) manufactured by Jerome Medical. Descri…
Jerome Medical1995—
†K051918Resolve Open Back Halo RingsJerome Medical20057

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 HAX devices

HAX Tong, Skull For Traction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

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—

What is it indicated for?

The ReSolve Tongs are intended for use to provide longitudinal traction to align vertebral structures, maintain reduction, or provide stabilization for a cervical spine injury.

Indications for use as stated in the FDA summary.

Recent decisions in HAX

The HAX category page

  • K090733PMT Halo SystemPmt Corp. · 2009
  • K051918Resolve Open Back Halo RingsJerome Medical · 20057 recalls
  • K023959Jerome Glass RingThe Jerome Group, Inc. · 20036 recalls
  • K003662Spine Works CollarSpine Works · 2001
  • K980689Friddle Halo System, Friddle Mri Halo SystemFriddle'S Orthopedic Appliances, Inc. · 1999

https://510kreport.com/device/K071173 · printed Nov 4, 2026

Cite this page

510(k) Report. “K071173: Resolve Tongs, Small/Medium, Resolve Tongs, Medium/Large, Model JT-200D, JT-100D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071173

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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