510(k) · Cleared

Cleared

Orthosorb Resorbable Pins

K111077510(k) TraditionalCleared Jul 12, 201185-day reviewClass II21 CFR 888.3040

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

DePuy Orthopaedics, Inc. · OVZ Pin, Fixation, Resorbable, Hard Tissue

Cleared on Jul 12, 2011 as substantially equivalent to K901456 (Johnson & Johnson International, 1990) after an 85-day review. Its family tree reaches back 1 generation to 1990. 1 later device descends from it.

Decided: Jul 12, 2011
Review: 85 days
Class: Class II
Product code: OVZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K901456 (1990). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
This deviceK111077 Orthosorb Resorbable PinsDePuy Orthopaedics, Inc. · 2011
Descendant · cites it directly · 0 of its ownK140625 Orthosorb LSBiomet, Inc. · 2014

Most influential descendants

Showing 1 of 1 · See all

K140625Orthosorb LSBiomet, Inc. · 2014 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K901456	Orthosorb (R) Absorbable Pin	Johnson & Johnson International	1990	—
0 (this device)	K111077	Orthosorb Resorbable Pins	DePuy Orthopaedics, Inc.	2011	—
+1	K140625	Orthosorb LS	Biomet, Inc.	2014	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2014	1	0

FIG. 1 — Lineage of K111077, 1990–2014Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K901456	Orthosorb (R) Absorbable Pin Summary page 1 …ation, Resorbable, Hard Tissue Name of Predicate The device is substantially equivalent to the currently marketed QRTHOSORB Devices Resorbable Pin, K(901456. Classification Class 11,Regulation Number 21 CFR 888.3040, Product Code OVZ Performance Performance standar…	Johnson & Johnson International	1990	—

Also cleared against K901456: 6 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K140625	Orthosorb LS	Biomet, Inc.	2014	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?

Its one ancestor has no recall.
Of its descendants, K140625 (Biomet, Inc., 2014) has gone furthest, with 0 descendants of its own.
6 other devices also cite its predicate K901456.

How does its category compare?

All OVZ devices

OVZ Pin, Fixation, Resorbable, Hard Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.

FDA decisions per year · OVZ

1in 2014

2007high 1 (2011) · low 0 (2007)2026

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

2007high 6 (2016) · low 0 (2007)2025

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	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	1	—	1
2012	0	—	0
2013	0	—	2
2014	1	—	5
2015	0	—	4
2016	0	—	6
2017	0	—	1
2018	0	—	1
2019	0	—	0
2020	0	—	0
2021	0	—	1
2022	0	—	0
2023	0	—	0
2024	0	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

The ORTHOSORB Resorbable pin are indicated for use 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; or for fixation of inherently stable osteotomies of the great toe and intramedullary stability of joint arthroplasty (resection) for the treatment of lesser toe deformities. The Resorbable Pin can be 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/K111077 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111077: Orthosorb Resorbable Pins.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111077

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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