510(k) Report

510(k) · Cleared

Cleared

Orthopedic Forceps

K780397510(k) TraditionalCleared Mar 22, 19789-day reviewClass I21 CFR 888.4540

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

Orthopedic Equipment Co., Inc. · HTX Rongeur

Cleared on Mar 22, 1978 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Mar 22, 1978
Review
9 days
Class
Class I
Product code
HTX
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K780397Source: FDA 510(k) database · 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 HTX? 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?

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.

How does its category compare?

All HTX devices

HTX Rongeur: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTX

FDA has decided no HTX device since 2007.

Median 510(k) review, days · HTX

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

Recalls per year · HTX

1in 2024

2024: 1
2007high 1 (2024) · low 0 (2007)2026

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

Adverse event reports per year · HTX

16in 2025

2007: 212008: 592009: 282010: 182011: 222012: 132013: 342014: 152015: 382016: 282017: 262018: 252019: 242020: 292021: 262022: 232023: 142024: 242025: 16
2007high 59 (2008) · low 13 (2012)2025

MAUDE reports naming product code HTX, 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
20070—021
20080—059
20090—028
20100—018
20110—022
20120—013
20130—034
20140—015
20150—038
20160—028
20170—026
20180—025
20190—024
20200—029
20210—026
20220—023
20230—014
20240—124
20250—016
20260—0—

More from Orthopedic Equipment Co., Inc.

45 FDA decisions under this applicant name. See the company

  • K834035Universal Self-Aligning Acetabular ComOrthopedic Equipment Co., Inc. · 1984
  • K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  • K800530Schlein Tri-Surface AnkleOrthopedic Equipment Co., Inc. · 1980
  • K781445SpreaderOrthopedic Equipment Co., Inc. · 1979
  • K790247Tourniquet Test GageOrthopedic Equipment Co., Inc. · 1979

Recent decisions in HTX

The HTX category page

  • K874954Manual RongeurSolway, Inc. · 1987
  • K841621Back Radius CutterPlastafil, Inc. · 1984
  • K841620Front Radius CutterPlastafil, Inc. · 1984
  • K760325Surgical Instruments, OrthopedicDepuy, Inc. · 1976

https://510kreport.com/device/K780397 · printed Nov 3, 2026

Cite this page

510(k) Report. “K780397: Orthopedic Forceps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K780397

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
  • Page last updated Nov 3, 2026