510(k) · Cleared
ClearedCohen Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Leibinger, Inc. · JEY Plate, Bone
Cleared on Aug 11, 1997 as substantially equivalent to K964649 (Howmedica Leibinger, Inc., 1997) and 3 other predicates after a 63-day review. Its family tree reaches back 3 generations to 1979. 8 later devices descend from it.
- Decided
- Aug 11, 1997
- Review
- 63 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K792561 (1979). 10 ancestors in all. 8 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK792561 Mini-H-FixationGeny Medical, Inc. · 1979
- 2 generations backK962272 Synthes Mandible DistractorSynthes (Usa) · 1996
- 1 generation backK964649 Vazquez Diner Intraoral Distraction DeviceHowmedica Leibinger, Inc. · 1997
- This deviceK972154 Cohen DistractorHowmedica Leibinger, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK092743 The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial · 2010
- Descendant · 2 generations on · 1 of its ownK133398 Stryker Pediatric Mandible DistractorStryker · 2014
- Descendant · cites it directly · 1 of its ownK982604 Lorenz Maxilla (LE Fort) Distraction SystemWalter Lorenz Surgical, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK973484 Chin DistractorHowmedica, Inc. · 1997
- Descendant · 3 generations on · 0 of its ownK181504 Stryker Pediatric Mandibular Distractor 2Stryker · 2018
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K092743The Leibinger Advance Internal Midface Distraction SystemStryker Craniomaxillofacial · 2010 · cites it directly3descendants
- K133398Stryker Pediatric Mandible DistractorStryker · 2014 · 2 generations on1descendant
- K982604Lorenz Maxilla (LE Fort) Distraction SystemWalter Lorenz Surgical, Inc. · 1998 · cites it directly1descendant
- K973484Chin DistractorHowmedica, Inc. · 1997 · cites it directly1descendant
- K181504Stryker Pediatric Mandibular Distractor 2Stryker · 2018 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K792561 | Mini-H-Fixation | Geny Medical, Inc. | 1979 | — |
| −2 | K962272 | Synthes Mandible Distractor | Synthes (Usa) | 1996 | — |
| −1 | K964649 | Vazquez Diner Intraoral Distraction Device | Howmedica Leibinger, Inc. | 1997 | — |
| 0 (this device) | K972154 | Cohen Distractor | Howmedica Leibinger, Inc. | 1997 | — |
| +1 | K092743 | The Leibinger Advance Internal Midface Distraction System | Stryker Craniomaxillofacial | 2010 | — |
| +2 | K133398 | Stryker Pediatric Mandible Distractor | Stryker | 2014 | — |
| +1 | K982604 | Lorenz Maxilla (LE Fort) Distraction System | Walter Lorenz Surgical, Inc. | 1998 | — |
| +1 | K973484 | Chin Distractor | Howmedica, Inc. | 1997 | — |
| +3 | K181504 | Stryker Pediatric Mandibular Distractor 2 | Stryker | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2003 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 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 JEY? 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 JEY device
- #1 K252246 Leforte MMF Systemscore 15.6 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K964649 | Vazquez Diner Intraoral Distraction DeviceSummary page 1…nce for this device is based on similarities in intended use, material, design and operational principle to the Vazquez - Diner Intraoral Distractor (Howmedica Leibinger K964649); the Mandibular Bone Distractor II (Howmedica K960297); the Normed Distractor (Ace Surgical Supply [US Distributor] K # Unknown)… | 1997 |
| * | K960297 | Mandibular Bone Distractor IISummary page 1…d use, material, design and operational principle to the Vazquez - Diner Intraoral Distractor (Howmedica Leibinger K964649); the Mandibular Bone Distractor II (Howmedica K960297); the Normed Distractor (Ace Surgical Supply [US Distributor] K # Unknown); the Luhr Small Fixation Plating System (Howmedica K95… | 1996 |
| * | K950595 | Luhr Mandibular/Small Fixation ImplantsSummary page 1…bular Bone Distractor II (Howmedica K960297); the Normed Distractor (Ace Surgical Supply [US Distributor] K # Unknown); the Luhr Small Fixation Plating System (Howmedica K950595) and the Synthes Midface Plating System (Synthes) K953806. 5: C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Heal… | 1995 |
| * | K953806 | Synthes (Usa) Midfacial SystemSummary page 1…istractor (Ace Surgical Supply [US Distributor] K # Unknown); the Luhr Small Fixation Plating System (Howmedica K950595) and the Synthes Midface Plating System (Synthes) K953806. 5: C DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service ‘""“z ) Food and Drug Administration 9200 Corp… | 1996 |
| * | — | Normed Distractor Named without a submission number |
What descends from it? (8)
5 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092743 | The Leibinger Advance Internal Midface Distraction System | 2010 | 3 |
| K982604 | Lorenz Maxilla (LE Fort) Distraction System | 1998 | 1 |
| K973484 | Chin Distractor | 1997 | 1 |
| K121235 | Leibinger Advance Internal Midface Distraction System | 2014 | 0 |
| K031708 | Osteomed Maxillary/Lefort Iii Distraction System | 2003 | 0 |
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 18 years and passes through 3 companies; a new generation was cleared every 7 months on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K092743 (Stryker Craniomaxillofacial, 2010) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K964649.
How does its category compare?
All JEY devicesJEY Plate, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JEY
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JEY
159in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JEY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JEY
1,003in 2025
MAUDE reports naming product code JEY, 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 | 9 | 115 | 0 | 29 |
| 2008 | 7 | 84 | 3 | 24 |
| 2009 | 4 | 121 | 6 | 93 |
| 2010 | 6 | 199 | 85 | 215 |
| 2011 | 5 | 75 | 0 | 241 |
| 2012 | 10 | 194 | 0 | 428 |
| 2013 | 8 | 126 | 1 | 766 |
| 2014 | 6 | 223 | 0 | 616 |
| 2015 | 7 | 160 | 0 | 767 |
| 2016 | 1 | — | 0 | 558 |
| 2017 | 5 | 190 | 0 | 568 |
| 2018 | 7 | 255 | 0 | 608 |
| 2019 | 6 | 163 | 0 | 595 |
| 2020 | 6 | 198 | 1 | 680 |
| 2021 | 4 | 299 | 0 | 451 |
| 2022 | 5 | 135 | 0 | 344 |
| 2023 | 2 | — | 0 | 495 |
| 2024 | 5 | 159 | 0 | 696 |
| 2025 | 2 | — | 0 | 1,003 |
| 2026 | 3 | 258 | 0 | — |
What is it indicated for?
This product is intended for use in the treatment of cranial, midface, or mandibular conditions for which reconstructive osteotomy and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and mandibular micrognathia. The device is intended to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones.
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/K972154 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972154: Cohen Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972154
Report an extraction error
Are you the manufacturer?
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