510(k) · Cleared
ClearedOsteomed Cranial Distraction System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed · PBJ Cranial Distraction System
Cleared on Aug 22, 2012 as substantially equivalent to K003883 (KLS-Martin L.P., 2001) after a 113-day review. Its family tree reaches back 1 generation to 2001. 2 later devices descend from it.
- Decided
- Aug 22, 2012
- Review
- 113 days
- Class
- Class II
- Product code
- PBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003883 (2001). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003883 Molina Orbital Malar DistractorKLS-Martin L.P. · 2001
- This deviceK121304 Osteomed Cranial Distraction SystemOsteomed · 2012
- Descendant · cites it directly · 1 of its ownK123885 Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013
- Descendant · 2 generations on · 0 of its ownK230211 CranioXpandKLS-Martin L.P. · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003883 | Molina Orbital Malar Distractor | KLS-Martin L.P. | 2001 | — |
| 0 (this device) | K121304 | Osteomed Cranial Distraction System | Osteomed | 2012 | — |
| +1 | K123885 | Osteomed Smartflex Cranial Spring Distractor | Osteomed LP | 2013 | — |
| +2 | K230211 | CranioXpand | KLS-Martin L.P. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 PBJ? 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 PBJ device
- #1 K230211 CranioXpandscore 7.9 · 6 generations · no Class I recall
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 |
|---|---|---|---|
| * | K003883 | Molina Orbital Malar DistractorSummary page 1…o PBJ Device Class: 11 Predicate Devices: KLS-Martin, K003883 Classification Name:o Bone Plate (21 CFR 872.4760, Product Code JEY) Devi… | 2001 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123885 | Osteomed Smartflex Cranial Spring Distractor | 2013 | 1 |
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?
How does its category compare?
All PBJ devicesPBJ Cranial Distraction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · PBJ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PBJ
Too few PBJ 510(k)s in any year since 2007 to give a median.
Recalls per year · PBJ
No recall names PBJ since 2007.
Adverse event reports per year · PBJ
4in 2025
MAUDE reports naming product code PBJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 4 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OsteoMed Cranial Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation.
The OsteoMed Cranial Distraction System implants are intended for single use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121304: Osteomed Cranial Distraction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121304
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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