510(k) · Cleared
ClearedOsteomed Smartflex Cranial Spring Distractor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osteomed LP · PBJ Cranial Distraction System
Cleared on Jun 3, 2013 as substantially equivalent to K121304 (Osteomed, 2012) and 2 other predicates after a 167-day review. Its family tree reaches back 5 generations to 1986. 1 later device descends from it.
- Decided
- Jun 3, 2013
- Review
- 167 days
- Class
- Class II
- Product code
- PBJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K864403 (1986). 13 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK864403 Monticelli Spinelli External Fixation SystemHowmedica Corp. · 1986
- 4 generations backK960297 Mandibular Bone Distractor IIHowmedica Corp. · 1996
- 3 generations backK981362 Synthes (Usa) External Multi Vector Mandible DistractorSynthes (Usa) · 1998
- 2 generations backK034027 KLS Martin 3DX External Distraction SystemKLS-Martin L.P. · 2004
- 1 generation backK063792 Osteomed External Mandibular Distraction SystemOsteomed LP · 2007
- This deviceK123885 Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013
- Descendant · cites it directly · 0 of its ownK230211 CranioXpandKLS-Martin L.P. · 2023
Most influential descendants
Showing 1 of 1 · See all- K230211CranioXpandKLS-Martin L.P. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K864403 | Monticelli Spinelli External Fixation System | Howmedica Corp. | 1986 | — |
| −4 | K960297 | Mandibular Bone Distractor II | Howmedica Corp. | 1996 | — |
| −3 | K981362 | Synthes (Usa) External Multi Vector Mandible Distractor | Synthes (Usa) | 1998 | — |
| −2 | K034027 | KLS Martin 3DX External Distraction System | KLS-Martin L.P. | 2004 | — |
| −1 | K063792 | Osteomed External Mandibular Distraction System | Osteomed LP | 2007 | — |
| 0 (this device) | K123885 | Osteomed Smartflex Cranial Spring Distractor | Osteomed LP | 2013 | — |
| +1 | K230211 | CranioXpand | KLS-Martin L.P. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K121304 | Osteomed Cranial Distraction SystemSummary page 1…CFR 882.5330 o Regulation Name: Preformed nonalterable cranioplasty plate o Product Code: PBJ Device Class: I Predicate Devices: OsteoMed Cranial Distraction System, K121304 o Classification Name: Regulation Number: 21 CFR 882.5330 o Regulation Name: Preformed nonalterable cranioplasty plate o Product… | 2012 |
| * | K003883 | Molina Orbital Malar DistractorSummary page 3…e of the OsteoMed smartflex Cranial Spring Distraction System are the same as the OsteoMed Cranial Distraction System (K121304) and KLS-Martin Molina Distraction System (K003883) predicate devices. Clinical Testing is not required to support substantial equivalence. In conclusion, the device is safe and… | 2001 |
| * | K063792 | Osteomed External Mandibular Distraction SystemSummary page 1…assification Name: Regulation Number: 21 CFR 872.4760 o Regulation Name: Bone Plate o Product Code: JEY Device Class: |l OsteoMed External Mandibular Distraction System, K063792 ' o Classification Name: Regulation Number: 872.4760 o Regulation Name: Bone Plate o Product Code: MQN Device Class: 1l OsteoMed… | 2007 |
| † | K922211 | Osteomed Great Toe System | 1993 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K230211 | CranioXpand | 2023 | 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 27 years and passes through 4 companies; a new generation was cleared every 5.7 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K230211 (KLS-Martin L.P., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PBJ devicesPBJ Cranial Distraction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 smartflex Cranial Spring 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 smartflex Cranial Spring Distraction System is intended for single patient use only.
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/K123885 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123885: Osteomed Smartflex Cranial Spring Distractor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123885
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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