510(k) Report

510(k) · Cleared

Cleared

Smith Subtalar Peg

K792670510(k) TraditionalCleared Feb 22, 198057-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

Dow Corning Wright · LXH Orthopedic Manual Surgical Instrument

Cleared on Feb 22, 1980 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 59 later devices descend from it.

Decided
Feb 22, 1980
Review
57 days
Class
Class I
Product code
LXH
Recalls
None
Predicates
0

59 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared2003: 3 descendants cleared2010: 2 descendants cleared2013: 1 descendant cleared2014: 3 descendants cleared2012: 1 descendant cleared2011: 5 descendants cleared2005: 1 descendant cleared2007: 1 descendant cleared2004: 1 descendant cleared2006: 1 descendant cleared2021: 4 descendants cleared2009: 1 descendant cleared2008: 2 descendants cleared2015: 5 descendants cleared2017: 3 descendants cleared2016: 3 descendants cleared2020: 2 descendants cleared2019: 4 descendants cleared2022: 1 descendant cleared2018: 1 descendant cleared2024: 4 descendants cleared2023: 2 descendants cleared2025: 3 descendants cleared2026: 4 descendants cleared19801990200020102020
  1. This deviceK792670 Smith Subtalar PegDow Corning Wright · 1980
  2. Descendant · cites it directly · 57 of its ownK960692 Subtalar Mba SystemKinetikos Medical, Inc. · 1996
  3. Descendant · 2 generations on · 32 of its ownK071498 Subtalar ImplantBiomet Sports Medicine, Inc. · 2007 · Recalled
  4. Descendant · 3 generations on · 31 of its ownK133636 Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014
  5. Descendant · 4 generations on · 16 of its ownK141857 CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015
  6. Descendant · 2 generations on · 16 of its ownK031155 Osteomed Subtalar Implant SystemOsteomed LP · 2003

Showing 5 of 59 descendants. See all descendants

Descendants cleared per year

1996: 12003: 32004: 12005: 12006: 12007: 12008: 22009: 12010: 22011: 52012: 12013: 12014: 32015: 52016: 32017: 32018: 12019: 42020: 22021: 42022: 12023: 22024: 42025: 32026: 4
1996high 5 (2011) · low 0 (1997)2026

Most influential descendants

Showing 5 of 59 · See all
  • K960692Subtalar Mba SystemKinetikos Medical, Inc. · 1996 · cites it directly57descendants
  • K071498Subtalar ImplantBiomet Sports Medicine, Inc. · 2007 · 2 generations on32descendants
  • K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC · 2014 · 3 generations on31descendants
  • K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem · 2015 · 4 generations on16descendants
  • K031155Osteomed Subtalar Implant SystemOsteomed LP · 2003 · 2 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K792670Smith Subtalar PegDow Corning Wright1980—
+1K960692Subtalar Mba SystemKinetikos Medical, Inc.1996—
+2K071498Subtalar ImplantBiomet Sports Medicine, Inc.20077
+3K133636Extremity Medical Hammertoe DeviceExtremity Medical, LLC2014—
+4K141857CrossTie Intraosseous Fixation SystemOrthodiscovery Group, LLC (D.B.A. Crossroads Extrem2015—
+2K031155Osteomed Subtalar Implant SystemOsteomed LP2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
200330
200410
200510
200610
200710
200820
200910
201020
201150
201210
201310
201430
201550
201630
201730
201810
201940
202020
202140
202210
202320
202440
202530
202640
FIG. 1 — Lineage of K792670, 1980–2026Source: 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LXH? 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? (59)

See all 59

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K960692Subtalar Mba SystemKinetikos Medical, Inc.199657
K033046Subtalar Peg ImplantNexa Orthopedics, Inc.20039
K093820Subfix Arthroereisis Implant, Models SUT0065, SUT0080, SUT0090, SUT0100, SUT0115Memometal Technologies20108

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, K960692 (Kinetikos Medical, Inc., 1996) has gone furthest, with 57 descendants of its own.

How does its category compare?

All LXH devices

LXH Orthopedic Manual Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LXH

1in 2019

2010: 12014: 12019: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LXH

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

Recalls per year · LXH

3in 2024

2007: 412008: 412009: 252010: 542011: 122012: 292013: 172014: 122015: 72016: 92017: 142018: 232019: 102020: 32021: 22022: 42023: 42024: 32026 (partial year): 8
2007high 54 (2010) · low 0 (2025)2026

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

Adverse event reports per year · LXH

6,119in 2025

2007: 3982008: 8332009: 1,5692010: 2,3292011: 2,4882012: 2,0592013: 4,1492014: 3,8442015: 5,9442016: 6,3652017: 4,1332018: 4,6852019: 5,2242020: 4,7662021: 4,8322022: 4,8442023: 5,1632024: 6,3192025: 6,119
2007high 6,365 (2016) · low 398 (2007)2025

MAUDE reports naming product code LXH, 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—41398
20080—41833
20090—251,569
20101—542,329
20110—122,488
20120—292,059
20130—174,149
20141—123,844
20150—75,944
20160—96,365
20170—144,133
20180—234,685
20191—105,224
20200—34,766
20210—24,832
20220—44,844
20230—45,163
20240—36,319
20250—06,119
20260—8—

More from Dow Corning Wright

75 FDA decisions under this applicant name. See the company

  • K932210Ortholoc Advantim Revision Femoral ComponentDow Corning Wright · 1994
  • K932911Ortholoc Advantim L.S. Tibial ComponentDow Corning Wright · 1994
  • K934354Lacey All Polyethylene Tibial ComponentDow Corning Wright · 1994
  • K932222SLT Femoral HeadDow Corning Wright · 1994
  • K932858Ortholoc Advantim Tibial Base ComponentDow Corning Wright · 1994

Recent decisions in LXH

The LXH category page

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  • K952495Anchors Away Soft Tissue Attachment SystemOrthopedic Systems, Inc. · 1996

https://510kreport.com/device/K792670 · printed Nov 6, 2026

Cite this page

510(k) Report. “K792670: Smith Subtalar Peg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K792670

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