510(k) Report

510(k) · Cleared

Cleared

Orthofiber

K041894510(k) SpecialCleared Sep 17, 200466-day reviewClass II21 CFR 878.5000

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

Cp Medical · GAT Suture, Nonabsorbable, Synthetic, Polyethylene

Cleared on Sep 17, 2004 as substantially equivalent to K001172 (Cp Medical, 2000) and 2 other predicates after a 66-day review. Its family tree reaches back 3 generations to 1999. 4 later devices descend from it.

Decided
Sep 17, 2004
Review
66 days
Class
Class II
Product code
GAT
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K990088 (1999). 8 ancestors in all. 4 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 2 other ancestors2000: 3 other ancestors2009: 1 descendant cleared2010: 1 descendant cleared2005: 1 descendant cleared2007: 1 descendant clearedK990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 1999K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 20021995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 3 other ancestors 1 generation forward: 4 descendants K021434 · Arthrex Fiberwire in Usp Sizes · Arthrex, Inc. · 2002K012923 · Arthrex Fiberwire, Usp Size 5, Model AR-7201 · Arthrex, Inc. · 2001K990088 · Synthofil Nonabsorbable Pet Surgical Suture · Aesculap, Inc. · 19990
  1. Root · 3 generations backK990088 Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc. · 1999
  2. 2 generations backK012923 Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001
  3. 1 generation backK021434 Arthrex Fiberwire in Usp SizesArthrex, Inc. · 2002
  4. This deviceK041894 OrthofiberCp Medical · 2004
  5. Descendant · cites it directly · 0 of its ownK094028 CP-Fiber (Orthofiber)Cp Medical · 2010
  6. Descendant · cites it directly · 0 of its ownK082518 Dual Needle Suture Passer SystemCayenne Medical, Inc. · 2009
  7. Descendant · cites it directly · 0 of its ownK071796 Capsew Plication SystemCayenne Medical, Inc. · 2007
  8. Descendant · cites it directly · 0 of its ownK050150 Mani Needle & Suture PackMani, Inc. · 2005

Most influential descendants

Showing 4 of 4 · See all
  • K094028CP-Fiber (Orthofiber)Cp Medical · 2010 · cites it directly0descendants
  • K082518Dual Needle Suture Passer SystemCayenne Medical, Inc. · 2009 · cites it directly0descendants
  • K071796Capsew Plication SystemCayenne Medical, Inc. · 2007 · cites it directly0descendants
  • K050150Mani Needle & Suture PackMani, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K990088Synthofil Nonabsorbable Pet Surgical SutureAesculap, Inc.1999—
−2K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc.2001—
−1K021434Arthrex Fiberwire in Usp SizesArthrex, Inc.2002—
0 (this device)K041894OrthofiberCp Medical2004—
+1K094028CP-Fiber (Orthofiber)Cp Medical2010—
+1K082518Dual Needle Suture Passer SystemCayenne Medical, Inc.2009—
+1K071796Capsew Plication SystemCayenne Medical, Inc.2007—
+1K050150Mani Needle & Suture PackMani, Inc.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200030
200120

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200710
200910
201010
FIG. 1 — Lineage of K041894, 1999–2010Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 GAT? 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 GAT device

  1. #1 K230311 HyperSuturescore 20.2 · 7 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K001172Polyester Nonabsorbable Surgical Sutures Urp
Summary page 1
…2004 Predicate Device: The predicate device to the proposed CP Medical polyblend surgical suture, CP Fiber, is the existing CP Medical polyester surgical suture device, K001172 and Arthrex's FiberWIRE TM polyblend suture K010673, K021434. Both predicate and proposed devices are indicated for use in soft…
Cp Medical20001
*K010673Arthrex Fiberwire, Model Spu-02NB-3800
Summary page 1
…proposed CP Medical polyblend surgical suture, CP Fiber, is the existing CP Medical polyester surgical suture device, K001172 and Arthrex's FiberWIRE TM polyblend suture K010673, K021434. Both predicate and proposed devices are indicated for use in soft tissue approximation; both meet USP for nonabsorbabl…
Arthrex, Inc.2001—
*K021434Arthrex Fiberwire in Usp Sizes
Summary page 1
…CP Medical polyblend surgical suture, CP Fiber, is the existing CP Medical polyester surgical suture device, K001172 and Arthrex's FiberWIRE TM polyblend suture K010673, K021434. Both predicate and proposed devices are indicated for use in soft tissue approximation; both meet USP for nonabsorbable sutures…
Arthrex, Inc.2002—

Also cleared against K001172: 3 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K094028CP-Fiber (Orthofiber)Cp Medical20100
K082518Dual Needle Suture Passer SystemCayenne Medical, Inc.20090
K071796Capsew Plication SystemCayenne Medical, Inc.20070
K050150Mani Needle & Suture PackMani, Inc.20050

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 5 years and passes through 3 companies; a new generation was cleared every 1.9 years on median.
  • 2 of the 8 ancestors have a recall of any class.
  • Of its descendants, K094028 (Cp Medical, 2010) has gone furthest, with 0 descendants of its own.
  • 3 other devices also cite its predicate K001172.

How does its category compare?

All GAT devices

GAT Suture, Nonabsorbable, Synthetic, Polyethylene: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GAT

5in 2025

2007: 62008: 42009: 92010: 112011: 12012: 62013: 42014: 42015: 72016: 102017: 62018: 62019: 42020: 52021: 42022: 52023: 82024: 32025: 52026 (partial year): 5
2007high 11 (2010) · low 1 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GAT

30in 2025

2007: 40 days median2008: 93 days median2009: 57 days median2010: 27 days median2012: 61 days median2013: 123 days median2014: 45 days median2015: 125 days median2016: 139 days median2017: 57 days median2018: 95 days median2019: 79 days median2020: 201 days median2021: 92 days median2022: 109 days median2023: 220 days median2024: 140 days median2025: 30 days median2026 (partial year): 83 days median
2007high 220 (2023) · low 27 (2010)2026

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

Recalls per year · GAT

1in 2011

2007: 12010: 32011: 1
2007high 3 (2010) · low 0 (2008)2026

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

Adverse event reports per year · GAT

2,956in 2025

2007: 152008: 152009: 552010: 792011: 972012: 2532013: 2102014: 1652015: 6262016: 6882017: 1,1042018: 1,4532019: 1,2512020: 1,2202021: 1,6432022: 1,4192023: 2,0382024: 2,5972025: 2,956
2007high 2,956 (2025) · low 15 (2007)2025

MAUDE reports naming product code GAT, 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
2007640115
2008493015
2009957055
20101127379
20111—197
20126610253
201341230210
20144450165
201571250626
2016101390688
201765701,104
201869501,453
201947901,251
2020520101,220
202149201,643
2022510901,419
2023822002,038
2024314002,597
202553002,956
20265830—

What is it indicated for?

General soft tissue approximation including use in cardiovascular, ophthalmic and neurological procedures.

Indications for use as stated in the FDA summary.

Also cleared against K001172

3 other devices cite the same predicate.

  • K091574Silk Black Braided Surgical Sutures, Nylon Monofilament Blue and Black Surgical SuturesSupplidores Unidos Internacionales, S.A. · 2009
  • K033718Maxbraid Polyester Plus and Polyethylene Plus SutureArthrotek, Inc. · 2004
  • K012923Arthrex Fiberwire, Usp Size 5, Model AR-7201Arthrex, Inc. · 2001

More from Cp Medical

31 FDA decisions under this applicant name. See the company

  • K094028CP-Fiber (Orthofiber)Cp Medical · 2010
  • K072229MonoswiftCp Medical · 20071 recall
  • K071550Pre-Waxed Needles with Gold Fiduciary MarkersCp Medical · 2007
  • K060987OSCERA7 Synthetic Absorbable Bone Wax, Model OS31Cp Medical · 2006
  • K034062CP Sleeve and River SleeveCp Medical · 2004

Recent decisions in GAT

The GAT category page

  • K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda. · 2026
  • K261021EasyWhip FamilyWinter Innovations, Inc. · 2026
  • K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLC · 2026
  • K254275HyperSuture All Green Extension LineThreadstone, LLC · 2026
  • K254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda. · 2026

https://510kreport.com/device/K041894 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041894: Orthofiber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041894

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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