510(k) · Cleared
ClearedOrthosorb LS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · OVZ Pin, Fixation, Resorbable, Hard Tissue
Cleared on Apr 18, 2014 as substantially equivalent to K901456 (Johnson & Johnson International, 1990) and 2 other predicates after a 38-day review. Its family tree reaches back 2 generations to 1990.
- Decided
- Apr 18, 2014
- Review
- 38 days
- Class
- Class II
- Product code
- OVZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K901456 (1990). 3 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901456 | Orthosorb (R) Absorbable Pin | Johnson & Johnson International | 1990 | — |
| −1 | K111077 | Orthosorb Resorbable Pins | DePuy Orthopaedics, Inc. | 2011 | — |
| 0 (this device) | K140625 | Orthosorb LS | Biomet, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 OVZ? 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? (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 |
|---|---|---|---|
| * | K901456 | Orthosorb (R) Absorbable PinSummary page 1…Biomet's OrthoSorb [S is substantially equivalent to the currently marketed devices: Depuy's Orthosorb Resorbable Pins (K(901456 and K(111077), and Biomet's LactoSorb Bone Pin (K(990291). Device Description: Biomet OrthoSorb [S res… | 1990 |
| * | K111077 | Orthosorb Resorbable PinsSummary page 1…thoSorb [S is substantially equivalent to the currently marketed devices: Depuy's Orthosorb Resorbable Pins (K(901456 and K(111077), and Biomet's LactoSorb Bone Pin (K(990291). Device Description: Biomet OrthoSorb [S resorbable fixat… | 2011 |
| * | K990291 | Lactosorb Bone PinSummary page 1…currently marketed devices: Depuy's Orthosorb Resorbable Pins (K(901456 and K(111077), and Biomet's LactoSorb Bone Pin (K(990291). Device Description: Biomet OrthoSorb [S resorbable fixation devices include straight and tapered pin… | 1999 |
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 24 years and passes through 3 companies; a new generation was cleared every 20.9 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 6 other devices also cite its predicate K901456.
How does its category compare?
All OVZ devicesOVZ Pin, Fixation, Resorbable, Hard Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OVZ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · OVZ
Too few OVZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OVZ
No recall names OVZ since 2007.
Adverse event reports per year · OVZ
1in 2021
MAUDE reports naming product code OVZ, 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 | 1 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
1.) To fix in place small bony or chondral fragments in the knee and hand where such fragments are not in tension, as in the case of osteochondritis dissecans or fractures of the phalanges and metacarpals;
2.) For fixation of inherently stable osteatomies of the great toe and first metatarsal and intramedullary stabilization of joint arthroplasty (resection) for the treatment of lesser toe deformities.
3.) Used to provide additional support in cases of finger joint fusion and digit replantation where standard fixation or support techniques are also employed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140625: Orthosorb LS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140625
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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