510(k) · Cleared
ClearedSynthes (Usa) External Multi Vector Mandible Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · DZL Screw, Fixation, Intraosseous
Cleared on Jun 29, 1998 as substantially equivalent to K960297 (Howmedica Corp., 1996) after a 75-day review. Its family tree reaches back 2 generations to 1986. 5 later devices descend from it.
- Decided
- Jun 29, 1998
- Review
- 75 days
- Class
- Class II
- Product code
- DZL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K864403 (1986). 5 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK864403 Monticelli Spinelli External Fixation SystemHowmedica Corp. · 1986
- 1 generation backK960297 Mandibular Bone Distractor IIHowmedica Corp. · 1996
- This deviceK981362 Synthes (Usa) External Multi Vector Mandible DistractorSynthes (Usa) · 1998
- Descendant · cites it directly · 3 of its ownK034027 KLS Martin 3DX External Distraction SystemKLS-Martin L.P. · 2004
- Descendant · cites it directly · 2 of its ownK063792 Osteomed External Mandibular Distraction SystemOsteomed LP · 2007
- Descendant · 2 generations on · 1 of its ownK123885 Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013
- Descendant · 3 generations on · 0 of its ownK230211 CranioXpandKLS-Martin L.P. · 2023
- Descendant · cites it directly · 0 of its ownK183113 DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019
Most influential descendants
Showing 5 of 5 · See all- K034027KLS Martin 3DX External Distraction SystemKLS-Martin L.P. · 2004 · cites it directly3descendants
- K063792Osteomed External Mandibular Distraction SystemOsteomed LP · 2007 · cites it directly2descendants
- K123885Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013 · 2 generations on1descendant
- K230211CranioXpandKLS-Martin L.P. · 2023 · 3 generations on0descendants
- K183113DePuy Synthes Maxillofacial Portfolio - MR ConditionalSynthes (USA) Products, LLC · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K864403 | Monticelli Spinelli External Fixation System | Howmedica Corp. | 1986 | — |
| −1 | K960297 | Mandibular Bone Distractor II | Howmedica Corp. | 1996 | — |
| 0 (this device) | K981362 | Synthes (Usa) External Multi Vector Mandible Distractor | Synthes (Usa) | 1998 | — |
| +1 | K034027 | KLS Martin 3DX External Distraction System | KLS-Martin L.P. | 2004 | — |
| +1 | K063792 | Osteomed External Mandibular Distraction System | Osteomed LP | 2007 | — |
| +2 | K123885 | Osteomed Smartflex Cranial Spring Distractor | Osteomed LP | 2013 | — |
| +3 | K230211 | CranioXpand | KLS-Martin L.P. | 2023 | — |
| +1 | K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 DZL? 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 DZL device
- #1 K254286 Guided Bone Regeneration Systemscore 12.2 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K960297 | Mandibular Bone Distractor IISummary page 1…ell Road Paoli, PA 19301 (610) 647-9700 Contact: Sheri L. Musgnung Screw, Fixation, Intraosseous Class II, 21 CFR 872.4880 Howmedica’s Mandibular Bone Distractor II (K960297) The Synthes External MVMD is a bone lengthening and distraction device which is achieved by gradually activating the device in… | 1996 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 12 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K034027 (KLS-Martin L.P., 2004) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K960297.
How does its category compare?
All DZL devicesDZL Screw, Fixation, Intraosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DZL
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZL
263in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZL
3in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZL
70in 2025
MAUDE reports naming product code DZL, 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 | 1 | — | 0 | 4 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 1 | 8 |
| 2010 | 3 | 89 | 1 | 17 |
| 2011 | 2 | — | 0 | 12 |
| 2012 | 0 | — | 0 | 236 |
| 2013 | 1 | — | 3 | 178 |
| 2014 | 2 | — | 0 | 106 |
| 2015 | 1 | — | 0 | 103 |
| 2016 | 1 | — | 0 | 34 |
| 2017 | 3 | 277 | 0 | 74 |
| 2018 | 0 | — | 0 | 57 |
| 2019 | 2 | — | 0 | 50 |
| 2020 | 1 | — | 0 | 85 |
| 2021 | 1 | — | 0 | 55 |
| 2022 | 0 | — | 0 | 162 |
| 2023 | 2 | — | 0 | 100 |
| 2024 | 2 | — | 0 | 106 |
| 2025 | 4 | 263 | 0 | 70 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
Synthes External MVMD is intended for use as a bone stabilizer and lengthener for conditions such as mandibular hypoplasia or post-traumatic defects of the mandible, where gradual bone distraction is required. The device is ideal for treating any form of congenital mandibular hypoplasia, such as Hemifacial Micorsomia, Treacher Collins Syndrome, Nagers Syndrome, Pierre Robin Syndrome, Goldenhar Syndrome, Apert Syndrome, and Crouzon Syndrome.
Synthes External MVMD is also ideal for treating hypoplasias of an acquired origin such as from post-traumatic growth disorders associated with injury to the temporomandibular joint, temporomandibular ankylosis, and segmental loss of bone.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981362 · printed Nov 4, 2026
Cite this page
510(k) Report. “K981362: Synthes (Usa) External Multi Vector Mandible Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981362
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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