510(k) Report

510(k) · Cleared

Cleared

Lundeen Subtalar Peg Implant

K922292510(k) TraditionalCleared Oct 23, 1992161-day reviewClass II21 CFR 888.3040

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

Sgarlato Laboratories, Inc. · MJW Prosthesis, Subtalar, Plug, Polymer

Cleared on Oct 23, 1992 after a 161-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Oct 23, 1992
Review
161 days
Class
Class II
Product code
MJW
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K922292Source: 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.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, 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 MJW devices

MJW Prosthesis, Subtalar, Plug, Polymer: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MJW

FDA has decided no MJW device since 2007.

Median 510(k) review, days · MJW

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

Recalls per year · MJW

No recall names MJW since 2007.

Adverse event reports per year · MJW

1in 2017

2007: 12011: 22017: 1
2007high 2 (2011) · low 0 (2008)2025

MAUDE reports naming product code MJW, 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—00
20090—00
20100—00
20110—02
20120—00
20130—00
20140—00
20150—00
20160—00
20170—01
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Sgarlato Laboratories, Inc.

8 FDA decisions under this applicant name. See the company

  • K043204Sgarlato Labs Painfree Pump and Pain Control Infusion PumpSgarlato Laboratories, Inc. · 2005
  • K990101Pain Control Infusion PumpSgarlato Laboratories, Inc. · 1999
  • K982931Threaded Fixation PinSgarlato Laboratories, Inc. · 1998
  • K926262First MPJ Continuous Passive Motion DeviceSgarlato Laboratories, Inc. · 1994
  • K926237O'brien GoniometerSgarlato Laboratories, Inc. · 1993

Recent decisions in MJW

The MJW category page

  • K033046Subtalar Peg ImplantNexa Orthopedics, Inc. · 2003

https://510kreport.com/device/K922292 · printed Nov 6, 2026

Cite this page

510(k) Report. “K922292: Lundeen Subtalar Peg Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922292

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