510(k) · Cleared
ClearedCranioXpand
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KLS-Martin L.P. · PBJ Cranial Distraction System
Cleared on Nov 21, 2023 as substantially equivalent to K123885 (Osteomed LP, 2013) after a 299-day review. Its family tree reaches back 6 generations to 1986.
- Decided
- Nov 21, 2023
- Review
- 299 days
- Class
- Class II
- Product code
- PBJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K864403 (1986). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK864403 Monticelli Spinelli External Fixation SystemHowmedica Corp. · 1986
- 5 generations backK960297 Mandibular Bone Distractor IIHowmedica Corp. · 1996
- 4 generations backK981362 Synthes (Usa) External Multi Vector Mandible DistractorSynthes (Usa) · 1998
- 3 generations backK034027 KLS Martin 3DX External Distraction SystemKLS-Martin L.P. · 2004
- 2 generations backK063792 Osteomed External Mandibular Distraction SystemOsteomed LP · 2007
- 1 generation backK123885 Osteomed Smartflex Cranial Spring DistractorOsteomed LP · 2013
- This deviceK230211 CranioXpandKLS-Martin L.P. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K864403 | Monticelli Spinelli External Fixation System | Howmedica Corp. | 1986 | — |
| −5 | K960297 | Mandibular Bone Distractor II | Howmedica Corp. | 1996 | — |
| −4 | K981362 | Synthes (Usa) External Multi Vector Mandible Distractor | Synthes (Usa) | 1998 | — |
| −3 | K034027 | KLS Martin 3DX External Distraction System | KLS-Martin L.P. | 2004 | — |
| −2 | K063792 | Osteomed External Mandibular Distraction System | Osteomed LP | 2007 | — |
| −1 | K123885 | Osteomed Smartflex Cranial Spring Distractor | Osteomed LP | 2013 | — |
| 0 (this device) | 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 |
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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K123885 | Osteomed Smartflex Cranial Spring DistractorSummary page 5…882.5330 Product Code: PBJ Predicate Device: OsteoMed SmartFlex Cranial Spring Distraction System [K123885] Classification Name: Cranial Distraction System Regulation Description: Preformed non-alterable cranioplasty plat… | 2013 |
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?
- The line of descent spans 37 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- None of the 14 ancestors has a recall.
How does its category compare?
All PBJ devicesPBJ Cranial Distraction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 KLS Martin CranioXpand Spring system is indicated for use in the treatment of cranial conditions such as craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated for the infant pediatric subpopulation (29 days to < 2 years of age). The CranioXpand implants are implantable single-use products intended for temporary stabilization and distraction of the bony cranial roof during and after surgery. This device is intended to be removed after bone consolidation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230211 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230211: CranioXpand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230211
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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