510(k) Report

510(k) · Cleared

Cleared

Stryker External Fixation System

K071628510(k) TraditionalCleared Aug 10, 200757-day reviewClass II21 CFR 872.4760

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

Stryker Cmf · MQN External Mandibular Fixator And/Or Distractor

Cleared on Aug 10, 2007 as substantially equivalent to K053038 (Howmedica Osteonics Corp., 2005) and 5 other predicates after a 57-day review. Its family tree reaches back 1 generation to 1996. 1 later device descends from it.

Decided
Aug 10, 2007
Review
57 days
Class
Class II
Product code
MQN
Recalls
None
Predicates
6

Its longest line of descent runs back 1 generation to K961916 (1996). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2006: 1 other ancestor2005: 1 other ancestor2004: 1 other ancestor1997: 2 other ancestors2007: 1 descendant clearedK961916 · Hoffmann II Carbon Connecting Rod · Howmedica, Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 1 descendant K961916 · Hoffmann II Carbon Connecting Rod · Howmedica, Inc. · 19960
  1. Root · 1 generation backK961916 Hoffmann II Carbon Connecting RodHowmedica, Inc. · 1996
  2. This deviceK071628 Stryker External Fixation SystemStryker Cmf · 2007
  3. Descendant · cites it directly · 0 of its ownK072764 KLS Martin Xternal FixatorKLS Martin L.P. · 2007

Most influential descendants

Showing 1 of 1 · See all
  • K072764KLS Martin Xternal FixatorKLS Martin L.P. · 2007 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K961916Hoffmann II Carbon Connecting RodHowmedica, Inc.1996—
0 (this device)K071628Stryker External Fixation SystemStryker Cmf2007—
+1K072764KLS Martin Xternal FixatorKLS Martin L.P.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199720
200410
200510
200610

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K071628, 1996–2007Source: 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.

Planning a device in MQN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new MQN device

  1. #1 K220050 KLS Martin IPS Distractionscore 5.0 · 5 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (6)

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
*K053038Hoffmann II Compact Mri External Fixation System
Summary page 1
…Stryker® considers the Stryker® External Fixation System are substantially equivalent to the already cleared Hoffman II Compact MRI External Fixation System (K053038), Hoffman II Compact External Fixation System (K961916, K971755 & K973321), Synthes Medium External Fixation System…
Howmedica Osteonics Corp.2005—
*K961916Hoffmann II Carbon Connecting Rod
Summary page 1
…are substantially equivalent to the already cleared Hoffman II Compact MRI External Fixation System (K053038), Hoffman II Compact External Fixation System (K961916, K971755 & K973321), Synthes Medium External Fixation System-MR Safe (K040258) and Synthes Sterile Mandible External Fixat…
Howmedica, Inc.1996—
*K971755Hoffmann II Compact External Fixation System
Summary page 1
…antially equivalent to the already cleared Hoffman II Compact MRI External Fixation System (K053038), Hoffman II Compact External Fixation System (K961916, K971755 & K973321), Synthes Medium External Fixation System-MR Safe (K040258) and Synthes Sterile Mandible External Fixator (K0622…
Howmedica Corp.19971
*K973321Hoffmann II Compact Periarticular Clamp
Summary page 1
…quivalent to the already cleared Hoffman II Compact MRI External Fixation System (K053038), Hoffman II Compact External Fixation System (K961916, K971755 & K973321), Synthes Medium External Fixation System-MR Safe (K040258) and Synthes Sterile Mandible External Fixator (K062299). ===…
Howmedica, Inc.1997—
*K040258Synthes Medium External Fixation System-MR Safe
Summary page 1
…ernal Fixation System (K053038), Hoffman II Compact External Fixation System (K961916, K971755 & K973321), Synthes Medium External Fixation System-MR Safe (K040258) and Synthes Sterile Mandible External Fixator (K062299). DEPARTMENT OF HEALTH & HUMAN SERVICES…
Synthes (Usa)2004—
*K062299Synthes Sterile Mandible External Fixation Kit
Summary page 1
…ct External Fixation System (K961916, K971755 & K973321), Synthes Medium External Fixation System-MR Safe (K040258) and Synthes Sterile Mandible External Fixator (K062299). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service…
Synthes (Usa)2006—

Also cleared against K053038: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072764KLS Martin Xternal FixatorKLS Martin L.P.20070

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?

  • 1 of the 6 ancestors has a recall of any class.
  • Of its descendants, K072764 (KLS Martin L.P., 2007) has gone furthest, with 0 descendants of its own.
  • 2 other devices also cite its predicate K053038.

How does its category compare?

All MQN devices

MQN External Mandibular Fixator And/Or Distractor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · MQN

1in 2022

2007: 42008: 32012: 12014: 12015: 12016: 12017: 12018: 12019: 12022: 1
2007high 4 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQN

292in 2008

2007: 77 days median2008: 292 days median
2007high 292 (2008) · low 77 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MQN

1in 2014

2014: 1
2007high 1 (2014) · low 0 (2007)2026

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

Adverse event reports per year · MQN

34in 2025

2007: 52008: 82009: 112010: 202011: 262012: 1072013: 1792014: 572015: 932016: 872017: 752018: 1082019: 1222020: 862021: 1012022: 612023: 392024: 602025: 34
2007high 179 (2013) · low 5 (2007)2025

MAUDE reports naming product code MQN, 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
200747705
2008329208
20090—011
20100—020
20110—026
20121—0107
20130—0179
20141—157
20151—093
20161—087
20171—075
20181—0108
20191—0122
20200—086
20210—0101
20221—061
20230—039
20240—060
20250—034
20260—0—

What is it indicated for?

The Stryker® External Fixation System is intended to stabilize and provide treatment for fractures of the maxillofacial area, including severe open mandibular fractures, highly comminuted closed fractures, nonunions and delayed unions (especially associated with infection), fractures associated with infections, tumor resections, facial deformity corrections, gunshot wounds, pan facial fractures, burn maintenance, and bone grafting defects.

Indications for use as stated in the FDA summary.

Also cleared against K053038

2 other devices cite the same predicate.

  • K141760Orthofix Galaxy WristOrthofix Srl · 20141 recall
  • K111786Hoffmann 3 Modular External Fixation SystemStryker Corp. · 2012

More from Stryker Cmf

2 FDA decisions under this applicant name. See the company

  • K060750Stryker Injectable CementStryker Cmf · 2006

Recent decisions in MQN

The MQN category page

  • K220050KLS Martin IPS DistractionKLS Martin L.P. · 2022
  • K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
  • K181504Stryker Pediatric Mandibular Distractor 2Stryker · 2018
  • K162594Craniomaxillofacial Distraction System (CMFD)Synthes USA Products, LLC · 2017
  • K161470Internal Distraction - SterileKLS Martin L.P. · 2016

https://510kreport.com/device/K071628 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071628: Stryker External Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071628

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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