510(k) Report

510(k) · Cleared

Cleared

Orthosorb (R) Absorbable Pin

K901456510(k) TraditionalCleared Aug 15, 1990141-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

Johnson & Johnson International · OVZ Pin, Fixation, Resorbable, Hard Tissue

Cleared on Aug 15, 1990 after a 141-day review. The FDA summary names no predicate by number. 399 later devices descend from it.

Decided
Aug 15, 1990
Review
141 days
Class
Class II
Product code
OVZ
Recalls
None
Predicates
0

399 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared1999: 1 descendant cleared2001: 3 descendants cleared2011: 6 descendants cleared2003: 2 descendants cleared2005: 4 descendants cleared2014: 27 descendants cleared2008: 7 descendants cleared2004: 2 descendants cleared2006: 3 descendants cleared2009: 5 descendants cleared2015: 16 descendants cleared2007: 5 descendants cleared2019: 31 descendants cleared2017: 19 descendants cleared2018: 18 descendants cleared2023: 34 descendants cleared2016: 9 descendants cleared2013: 8 descendants cleared2020: 27 descendants cleared2024: 44 descendants cleared2025: 34 descendants cleared2021: 24 descendants cleared2012: 3 descendants cleared2022: 25 descendants cleared2026: 41 descendants cleared1990200020102020
  1. This deviceK901456 Orthosorb (R) Absorbable PinJohnson & Johnson International · 1990
  2. Descendant · cites it directly · 382 of its ownK031712 Inion Otps Biodegradable PinInion, Ltd. · 2003
  3. Descendant · 2 generations on · 309 of its ownK033717 Transet Fracture Fixation SystemBonutti Research, Inc. · 2004
  4. Descendant · 3 generations on · 306 of its ownK043248 Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS…Arthrex, Inc. · 2005
  5. Descendant · 4 generations on · 217 of its ownK052776 Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel…Arthrex, Inc. · 2005
  6. Descendant · 4 generations on · 94 of its ownK083070 Toggleloc SystemBiomet Sports Medicine · 2008 · Recalled

Showing 5 of 399 descendants. See all descendants

Descendants cleared per year

1999: 12001: 32003: 22004: 22005: 42006: 32007: 52008: 72009: 52010: 12011: 62012: 32013: 82014: 272015: 162016: 92017: 192018: 182019: 312020: 272021: 242022: 252023: 342024: 442025: 342026: 41
1999high 44 (2024) · low 0 (2000)2026

Most influential descendants

Showing 5 of 399 · See all
  • K031712Inion Otps Biodegradable PinInion, Ltd. · 2003 · cites it directly382descendants
  • K033717Transet Fracture Fixation SystemBonutti Research, Inc. · 2004 · 2 generations on309descendants
  • K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel. Model…Arthrex, Inc. · 2005 · 3 generations on306descendants
  • K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models AR-2257…Arthrex, Inc. · 2005 · 4 generations on217descendants
  • K083070Toggleloc SystemBiomet Sports Medicine · 2008 · 4 generations on94descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K901456Orthosorb (R) Absorbable PinJohnson & Johnson International1990—
+1K031712Inion Otps Biodegradable PinInion, Ltd.2003—
+2K033717Transet Fracture Fixation SystemBonutti Research, Inc.2004—
+3K043248Tightrope Syndesmosis Repair Kit, Titanium, Model AR-8920DS; Stainless Steel.…Arthrex, Inc.2005—
+4K052776Tightrope Acromioclavicular (AC) Device, Titanium, Stainless Steel , Models…Arthrex, Inc.2005—
+4K083070Toggleloc SystemBiomet Sports Medicine20086

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200130
200320
200420
200540
200630
200750
200870
200950
201010
201160
201230
201380
2014270
2015160
201690
2017190
2018180
2019310
2020270
2021240
2022250
2023340
2024440
2025340
2026410
FIG. 1 — Lineage of K901456, 1990–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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
Get a 510(k) Report

What was it cleared against?

The FDA summary names no predicate by number.

What descends from it? (399)

See all 399

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K031712Inion Otps Biodegradable PinInion, Ltd.2003382
K993074Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525Bionx Implants, Ltd.19997
K092590PDS PlatesETHICON, Inc.20105
K111077Orthosorb Resorbable PinsDePuy Orthopaedics, Inc.20111
K043339Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070LG, 2770LG…Xtremi-T, LLC20051
K140625Orthosorb LSBiomet, Inc.20140
K011451Reunite Fusion ScrewBiomet, Inc.20010

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?

  • Of its descendants, K031712 (Inion, Ltd., 2003) has gone furthest, with 382 descendants of its own.

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.

FDA decisions per year · OVZ

1in 2014

2011: 12014: 1
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

2011: 12013: 22014: 52015: 42016: 62017: 12018: 12021: 1
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20111—01
20120—00
20130—02
20141—05
20150—04
20160—06
20170—01
20180—01
20190—00
20200—00
20210—01
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Johnson & Johnson International

10 FDA decisions under this applicant name. See the company

  • K965198Ultima TPS Cemented StemJohnson & Johnson International · 1997
  • K944937Synthetic Absorbable SutureJohnson & Johnson International · 1995
  • K946245Tielle* Hydropolymer DressingJohnson & Johnson International · 1995
  • K942383Dermiview Clear TapeJohnson & Johnson International · 1994
  • K922918Barrier Saf-TE Hydrogel DrapeJohnson & Johnson International · 1993

Recent decisions in OVZ

The OVZ category page

  • K140625Orthosorb LSBiomet, Inc. · 2014
  • K111077Orthosorb Resorbable PinsDePuy Orthopaedics, Inc. · 2011

https://510kreport.com/device/K901456 · printed Nov 6, 2026

Cite this page

510(k) Report. “K901456: Orthosorb (R) Absorbable Pin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901456

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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