510(k) · Cleared
ClearedNormed BI-Directional/Multidirectional Jaw Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomedics, Inc. · JEY Plate, Bone
Cleared on Aug 1, 2002 as substantially equivalent to K952847 (Ace Surgical Supply Co., Inc., 1996) after a 94-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Aug 1, 2002
- Review
- 94 days
- Class
- Class II
- Product code
- JEY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K952847 (1996). No later device cites it as a predicate yet.
- Root · 1 generation backK952847 Normed Bidirectrional/Multidirectional Jaw DistractorAce Surgical Supply Co., Inc. · 1996
- This deviceK021342 Normed BI-Directional/Multidirectional Jaw DistractorOsteomedics, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K952847 | Normed Bidirectrional/Multidirectional Jaw Distractor | Ace Surgical Supply Co., Inc. | 1996 | — |
| 0 (this device) | K021342 | Normed BI-Directional/Multidirectional Jaw Distractor | Osteomedics, Inc. | 2002 | — |
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? (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 |
|---|---|---|---|
| * | K952847 | Normed Bidirectrional/Multidirectional Jaw DistractorSummary page 1…ixator and/or Distractor Regulatory Class: I1 Product Code: Product Code: JEY Introduction of Normed Bi-Directional / Multi-Directional Jaw Distractor 5 10 (k) number K952847, by an additional distributor, Osteomedics@Inc. The Normed Bi-Directional / Multi-Directional Jaw Distractor is authorized by Fo… | 1996 |
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?
- Its one ancestor has no recall.
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?
The intended use of the Normed Bi-Directional/ Multi-Directional Jaw Distractor is identical to the description in the 510(k) number K952847 in which, the Normed Bi-Directional / Multi-Directional Jaw Distractor is designed for use in bone elongation which takes into account and can reproduce the normal size and shape of the facial skeleton. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with…
Read the full statement (130 words)
The intended use of the Normed Bi-Directional/ Multi-Directional Jaw Distractor is identical to the description in the 510(k) number K952847 in which, the Normed Bi-Directional / Multi-Directional Jaw Distractor is designed for use in bone elongation which takes into account and can reproduce the normal size and shape of the facial skeleton. As clinically defined the gradual step lengthening of a callus for distraction osteogenesis can be achieved with the transitory use of the Normed Bi-Directional / Multi-Directional Jaw Distractor. This Normed Bi -Directional / Multi-Directional Jaw Distractor device is indicated for use in maxillofacial alveolar and small craniofacial skeletal bones. Clinical indications are, sever open mandibular fractures, highly comminuted closed fractures, nonunion and delayed union, fractures associated with infection, tumor resections, facial deformity corrections, and bone - grafting defects.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021342 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021342: Normed BI-Directional/Multidirectional Jaw Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021342
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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