510(k) · Cleared
ClearedRxG Distraction System
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 Aug 27, 2015 after a 156-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Aug 27, 2015
- Review
- 156 days
- Class
- Class II
- Product code
- PBJ
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K002083 | FDA’s K002083 is Lorenz Resorbable Distractor System Our reading of the summary gave K002083, FDA’s number for Lorenz Resorbable Distractor System (Walter Lorenz Surgical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “LactoSorb Distraction”. Kept off the family tree. Summary page 4…d nonalterable cranioplasty plate Class II, 21 CFR 882.5330, Product Code PBJ Primary Predicate: LactoSorb Distraction (K002083) Reference Devices: RxG Distraction System (K133304) Resorb-X G (K121606) Dev… | 2001 |
| † | K133304 | RXG Distraction System | 2014 |
| † | K121606 | Resorb-X G | 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.
How does its category compare?
All PBJ devicesPBJ Cranial Distraction System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 RxG Distraction System includes devices intended for use in bone stabilization and elongation (lengthening) in the correction of congenital or developmental defects in cranial reconstruction for the pediatric and adult populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150771 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150771: RxG 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/K150771
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026