510(k) Report

510(k) · Cleared

Cleared

Orthocord

K123668510(k) TraditionalCleared Feb 26, 201389-day reviewClass II21 CFR 878.4840

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

Depuy Mitek, Inc., A Johnson and Johnson Company · NEW Suture, Surgical, Absorbable, Polydioxanone

Cleared on Feb 26, 2013 as substantially equivalent to K040004 (Depuy Mitek, 2004) and 8 other predicates after an 89-day review. Its family tree reaches back 8 generations to 1990.

Decided
Feb 26, 2013
Review
89 days
Class
Class II
Product code
NEW
Recalls
None
Predicates
9

Its longest line of descent runs back 8 generations to K904436 (1990). 52 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2008: 1 other ancestor2007: 2 other ancestors2004: 5 other ancestors2002: 4 other ancestors1995: 3 other ancestors2003: 4 other ancestors2001: 4 other ancestors2000: 4 other ancestors1999: 4 other ancestors1998: 3 other ancestors1996: 5 other ancestors1994: 1 other ancestor1992: 2 other ancestors1997: 1 other ancestor1993: 1 other ancestorK904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 1990K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 1996K973015 · Multitak SS Suture System · Bonutti Research · 1997K990156 · Multitak SS Buttons · Bonutti Research · 1999K031666 · Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS · Arthrex, Inc. · 2003 · recalledK062747 · Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM · Arthrex, Inc. · 2006K100652 · Acl Tightrope · Arthrex, Inc. · 2010K122374 · Arthrex Suture (Uhmwpe) · Arthrex, Inc. · 2012199019952000200520102015
Other ancestors, by generation 1 generation back: 8 other ancestors2 generations back: 17 other ancestors3 generations back: 7 other ancestors4 generations back: 5 other ancestors5 generations back: 4 other ancestors6 generations back: 2 other ancestors7 generations back: 1 other ancestor K122374 · Arthrex Suture (Uhmwpe) · Arthrex, Inc. · 2012K100652 · Acl Tightrope · Arthrex, Inc. · 2010K062747 · Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM · Arthrex, Inc. · 2006K031666 · Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS · Arthrex, Inc. · 2003 · recalledK990156 · Multitak SS Buttons · Bonutti Research · 1999K973015 · Multitak SS Suture System · Bonutti Research · 1997K962397 · Statak Soft Tissue Attachment Device · Zimmer, Inc. · 1996K904436 · Quickanchor (TM) · Mitek Surgical Products, Inc. · 1990−50
  1. Root · 8 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
  2. 7 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
  3. 6 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
  4. 5 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
  5. 4 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
  6. 3 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
  7. 2 generations backK100652 Acl TightropeArthrex, Inc. · 2010
  8. 1 generation backK122374 Arthrex Suture (Uhmwpe)Arthrex, Inc. · 2012
  9. This deviceK123668 OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K904436Quickanchor (TM)Mitek Surgical Products, Inc.1990—
−7K962397Statak Soft Tissue Attachment DeviceZimmer, Inc.1996—
−6K973015Multitak SS Suture SystemBonutti Research1997—
−5K990156Multitak SS ButtonsBonutti Research1999—
−4K031666Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc.20031
−3K062747Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc.2006—
−2K100652Acl TightropeArthrex, Inc.2010—
−1K122374Arthrex Suture (Uhmwpe)Arthrex, Inc.2012—
0 (this device)K123668OrthocordDepuy Mitek, Inc., A Johnson and Johnson Company2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199310
199410
199530
199650
199710
199830
199940
200040
200140
200240
200340
200450
200720
200810
FIG. 1 — Lineage of K123668, 1990–2013Source: 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 NEW? 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 NEW device

  1. #1 K252047 STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue…score 15.3 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (9)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K040004Orthocord Suture
Summary page 1
…Common Name: Suture Substantial The Small Size Orthocord® Suture is substantially equivalent to: Equivalence *K040004: Orthocord® Suture (USP Size 2, Violet) (April 13, 2004) Facility *K043298: Orthocord® Suture (USP S…
Depuy Mitek20041
*K043298Blue Orthocord Suture
Summary page 1
…d® Suture is substantially equivalent to: Equivalence *K040004: Orthocord® Suture (USP Size 2, Violet) (April 13, 2004) Facility *K043298: Orthocord® Suture (USP Size 2, Blue) (Dec 10, 2004) *K07 1257: Minilok Anchor with #2-0 Ortho…
Depuy Mitek20046
*K071257Mini Quickanchor and Quickanchor Plus with Orthocord
Summary page 1
…uture (USP Size 2, Violet) (April 13, 2004) Facility *K043298: Orthocord® Suture (USP Size 2, Blue) (Dec 10, 2004) *K07 1257: Minilok Anchor with #2-0 Orthocord® Suture (Jun 29, 2007) *K080352: Microfix Anchor with #3-0 and…
Depuy Mitek, A Johnson & Johnson Company2007—
*K080352Micro QA+ Anchor Witht #3-0 Orthocord Suture, Model 212843, Microfix AQ+ Anchor with…
Summary page 1
…uture (USP Size 2, Blue) (Dec 10, 2004) *K07 1257: Minilok Anchor with #2-0 Orthocord® Suture (Jun 29, 2007) *K080352: Microfix Anchor with #3-0 and 4-0 Orthocord® Suture (Mar 12, 2008) *K946 173: Ethibond Suture (Jan…
Depuy Mitek, A Johnson & Johnson Company2008—
*K946173Stainless Steel, Gut, Poly (Glycolide/L-Lactide) Polyamide, Polypropylene, Poly…
Summary page 1
…rthocord® Suture (Jun 29, 2007) *K080352: Microfix Anchor with #3-0 and 4-0 Orthocord® Suture (Mar 12, 2008) *K946 173: Ethibond Suture (January 09, 1995) *K022715: Vicryl Suture (December 19, 2002)…
ETHICON, Inc.199510
*K022715Coated Vicryl Plus Antimicrobial (Polyglactin 910) Suture
Summary page 1
…ofix Anchor with #3-0 and 4-0 Orthocord® Suture (Mar 12, 2008) *K946 173: Ethibond Suture (January 09, 1995) *K022715: Vicryl Suture (December 19, 2002) SK122374, K071622, K041553: Fiberwire FiberLoop Suture (Septembe…
ETHICON, Inc.20021
*K122374Arthrex Suture (Uhmwpe)
Summary page 1
…*K946 173: Ethibond Suture (January 09, 1995) *K022715: Vicryl Suture (December 19, 2002) SK122374, K071622, K041553: Fiberwire FiberLoop Suture (September 25, 2012; July 03, 2007; December 10, 20…
Arthrex, Inc.2012—
*K071622Arthrex Fiberwire
Summary page 1
…*K946 173: Ethibond Suture (January 09, 1995) *K022715: Vicryl Suture (December 19, 2002) SK122374, K071622, K041553: Fiberwire FiberLoop Suture (September 25, 2012; July 03, 2007; December 10, 2004) Devi…
Arthrex, Inc.2007—
*K041553Arthrex Suture Grafting Kit
Summary page 1
…*K946 173: Ethibond Suture (January 09, 1995) *K022715: Vicryl Suture (December 19, 2002) SK122374, K071622, K041553: Fiberwire FiberLoop Suture (September 25, 2012; July 03, 2007; December 10, 2004) Device…
Arthrex, Inc.2004—

Also cleared against K040004: 9 other devices →

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 23 years and passes through 5 companies; a new generation was cleared every 2.9 years on median.
  • 8 of the 52 ancestors have a recall of any class.
  • 9 other devices also cite its predicate K040004.

How does its category compare?

All NEW devices

NEW Suture, Surgical, Absorbable, Polydioxanone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · NEW

6in 2025

2007: 22008: 52010: 32011: 12012: 32013: 52014: 12015: 22016: 32017: 12018: 32019: 42020: 32021: 12022: 12023: 12024: 32025: 62026 (partial year): 5
2007high 6 (2025) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NEW

146in 2025

2008: 22 days median2010: 270 days median2012: 113 days median2013: 32 days median2016: 254 days median2018: 441 days median2019: 144 days median2020: 230 days median2024: 48 days median2025: 146 days median2026 (partial year): 264 days median
2007high 441 (2018) · low 22 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NEW

1in 2022

2008: 12009: 42012: 12013: 12014: 12019: 22022: 1
2007high 4 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NEW

2,504in 2025

2007: 72008: 292009: 422010: 1152011: 592012: 822013: 1852014: 2742015: 2802016: 3212017: 4612018: 9002019: 1,1222020: 1,0102021: 1,4662022: 1,5372023: 1,9752024: 2,1142025: 2,504
2007high 2,504 (2025) · low 7 (2007)2025

MAUDE reports naming product code NEW, 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
20072—07
2008522129
20090—442
201032700115
20111—059
20123113182
20135321185
20141—1274
20152—0280
201632540321
20171—0461
201834410900
2019414421,122
2020323001,010
20211—01,466
20221—11,537
20231—01,975
202434802,114
2025614602,504
202652640—

What is it indicated for?

The Small Size ORTHOCORD® Suture is indicated for:

ORTHOCORD Suture is indicated for use in general soft tissue approximation, and/or ligation, including orthopaedic procedures.

Indications for use as stated in the FDA summary.

Also cleared against K040004

9 other devices cite the same predicate.

  • K162247PermatapeMedos International SARL · 2016
  • K161638SPEEDTRAP Graft Preparation SystemMedos International SARL · 2016
  • K130814Rigidloop Fixation Device (15MM, 60MM, XL, 20MM, 25MM, 30MM, 35MM, 40MM, 45MM, 50MM, 55MMDepuy Mitek, A Johnson & Johnson Company · 2013
  • K094028CP-Fiber (Orthofiber)Cp Medical · 2010
  • K082282Healix TI AnchorDepuy Mitek, A Johnson & Johnson Co. · 2008
  • K080918Double Armed Meniscal Needles with Size #2-0 Orthocord, Meniscal Needle with Wire Eyelet & 3 Free Strands of…Depuy Mitek · 2008

More from Depuy Mitek, Inc., A Johnson and…

3 FDA decisions under this applicant name. See the company

  • K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013
  • K1221236-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw 8-10MM X 30 MM Intrafix…Depuy Mitek, Inc., A Johnson and Johnson Company · 2012

Recent decisions in NEW

The NEW category page

  • K254238MINT MONO SuturesHans Biomed Corporation · 2026
  • K253879Monofix PdoSamyang Holdings Corporation · 2026
  • K261988Monodek™ (POLYDIOXANONE) Dyed Violet Monofilament Synthetic Absorbable Surgical SutureTeleflex Medical, LLC · 2026
  • K252171Barbed PDO SutureSutura Medical Technology, Inc. · 2026
  • K252047STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control DevicesETHICON, Inc. · 2026

https://510kreport.com/device/K123668 · printed Nov 6, 2026

Cite this page

510(k) Report. “K123668: Orthocord.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123668

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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