510(k) Report

510(k) · Cleared

Cleared

Hedleyl Intramedullary Preparation Brush

K931737510(k) TraditionalCleared Jan 7, 1994275-day reviewClass I21 CFR 878.4800

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

Synvasive Technology, Inc. · HTZ Instrument, Cutting, Orthopedic

Cleared on Jan 7, 1994 after a 275-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 7, 1994
Review
275 days
Class
Class I
Product code
HTZ
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K931737Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in HTZ? 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
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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 HTZ devices

HTZ Instrument, Cutting, Orthopedic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HTZ

FDA has decided no HTZ device since 2007.

Median 510(k) review, days · HTZ

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

Recalls per year · HTZ

10in 2008

2008: 10
2007high 10 (2008) · low 0 (2007)2026

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

Adverse event reports per year · HTZ

136in 2025

2007: 12009: 12010: 32011: 32012: 32013: 472014: 182015: 152016: 342017: 322018: 472019: 1082020: 882021: 2282022: 1952023: 1872024: 2252025: 136
2007high 228 (2021) · low 0 (2008)2025

MAUDE reports naming product code HTZ, 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—01
20080—100
20090—01
20100—03
20110—03
20120—03
20130—047
20140—018
20150—015
20160—034
20170—032
20180—047
20190—0108
20200—088
20210—0228
20220—0195
20230—0187
20240—0225
20250—0136
20260—0—

More from Synvasive Technology, Inc.

10 FDA decisions under this applicant name. See the company

  • K093046Elibra Uni Soft-Tissue Force Sensor, Model 61-XXXX (5 Models, Different SizesSynvasive Technology, Inc. · 2011
  • K070108Elibra Dynamic Knee BalancerSynvasive Technology, Inc. · 2007
  • K972508Surgical Burs and Surgical Drill BitsSynvasive Technology, Inc. · 1997
  • K961522Kirschner Wire (K-Wire) and Steinmann PinSynvasive Technology, Inc. · 1996
  • K950009Powergrip (TM) Compression Fixation DeviceSynvasive Technology, Inc. · 1995

Recent decisions in HTZ

The HTZ category page

  • K933933CeboplaneSynvasive Technology, Inc. · 1994
  • K87088245 Degree ShaverBowen & Company, Inc. · 1987
  • K853678Kambin Spinal Instrument SetPilling Co. · 1985
  • K850527Arthroscopy Suction Biopsy PunchT. Korossurgical Instruments Corp. · 1985
  • K850423Concept Suction SleeveConcept, Inc. · 1985

https://510kreport.com/device/K931737 · printed Nov 4, 2026

Cite this page

510(k) Report. “K931737: Hedleyl Intramedullary Preparation Brush.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K931737

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