510(k) · Cleared
ClearedKLS Martin Xternal Fixator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS Martin L.P. · MQN External Mandibular Fixator And/Or Distractor
Cleared on Dec 20, 2007 as substantially equivalent to K071628 (Stryker Cmf, 2007) and 2 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1996.
- Decided
- Dec 20, 2007
- Review
- 83 days
- Class
- Class II
- Product code
- MQN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K961916 (1996). 9 ancestors in all, the oldest K901095 (1990). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K961916 | Hoffmann II Carbon Connecting Rod | Howmedica, Inc. | 1996 | — |
| −1 | K071628 | Stryker External Fixation System | Stryker Cmf | 2007 | — |
| 0 (this device) | K072764 | KLS Martin Xternal Fixator | KLS Martin L.P. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1997 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
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 K220050 KLS Martin IPS Distractionscore 5.0 · 5 generations · no Class I recall
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K071628 | Stryker External Fixation SystemSummary page 1…ator and/or Distractor (21 CFR 872.4760) Regulatory Class: II Predicate Devices: Stryker External Fixation System (K071628) Synthes Mandible External Fixator (K050378) Bi-Phase Set, Oral… | 2007 |
| * | K050378 | Synthes Mandible External FixatorSummary page 1…ulatory Class: II Predicate Devices: Stryker External Fixation System (K071628) Synthes Mandible External Fixator (K050378) Bi-Phase Set, Oral, Maxillofacial Surgery (K901095) Inten… | 2005 |
| * | K901095 | BI-Phase Set, Oral, Maxillofacial SurgerySummary page 1…Synthes Mandible External Fixator (K050378) Bi-Phase Set, Oral, Maxillofacial Surgery (K901095) Intended Use: KLS Martin Xternal Fixator is intended to stabilize and provide trea… | 1990 |
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.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
How does its category compare?
All MQN devicesMQN 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
2026 to Oct 25, outlined.
Median 510(k) review, days · MQN
292in 2008
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQN
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQN
34in 2025
MAUDE reports naming product code MQN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 77 | 0 | 5 |
| 2008 | 3 | 292 | 0 | 8 |
| 2009 | 0 | — | 0 | 11 |
| 2010 | 0 | — | 0 | 20 |
| 2011 | 0 | — | 0 | 26 |
| 2012 | 1 | — | 0 | 107 |
| 2013 | 0 | — | 0 | 179 |
| 2014 | 1 | — | 1 | 57 |
| 2015 | 1 | — | 0 | 93 |
| 2016 | 1 | — | 0 | 87 |
| 2017 | 1 | — | 0 | 75 |
| 2018 | 1 | — | 0 | 108 |
| 2019 | 1 | — | 0 | 122 |
| 2020 | 0 | — | 0 | 86 |
| 2021 | 0 | — | 0 | 101 |
| 2022 | 1 | — | 0 | 61 |
| 2023 | 0 | — | 0 | 39 |
| 2024 | 0 | — | 0 | 60 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
KLS Martin Xternal Fixator 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 facialfractures, burn maintenance, and bone grafting defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072764 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072764: KLS Martin Xternal Fixator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072764
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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