510(k) Report

510(k) · Cleared

Cleared

Polymer Threaded Anchor

K983169510(k) TraditionalCleared Dec 16, 199897-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

Orthopaedic Biosystems, Ltd. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Dec 16, 1998 as substantially equivalent to K972326 (Orthopaedic Biosystems, Ltd., 1998) and 1 other predicate after a 97-day review. Its family tree reaches back 1 generation to 1996.

Decided
Dec 16, 1998
Review
97 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K963402 (1996). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1998: 1 other ancestorK963402 · Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener · Innovasive Devices, Inc. · 1996199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor K963402 · Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener · Innovasive Devices, Inc. · 19960
  1. Root · 1 generation backK963402 Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone…Innovasive Devices, Inc. · 1996
  2. This deviceK983169 Polymer Threaded AnchorOrthopaedic Biosystems, Ltd. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K963402Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone FastenerInnovasive Devices, Inc.1996—
0 (this device)K983169Polymer Threaded AnchorOrthopaedic Biosystems, Ltd.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
FIG. 1 — Lineage of K983169, 1996–1998Source: 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 MBI? 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 MBI device

  1. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 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? (2)

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
*K972326Peba Anchor/Suture Combination
Summary page 1
…device is the “Polymer Threaded Anchor” (K983169). The purpose of this submission is to obtain clearance for a polymer version of the “PeBA Anchor /Suture Combination” (K972326) forming a new device called, “Polymer Threaded Anchor”. Changing the material used for the implant requires a 510(k) submission.…
Orthopaedic Biosystems, Ltd.19981
*K963402Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener
Summary page 1
…These include: “PeBA Anchor / Suture Combination” by Orthopaedic Biosystems Ltd., Inc. (K927236) and the “2.8 and 3.5mm ROC Suture Bone Fastener” by Innovasive Devices (K963402). DEVICE DESCRIPTION: Overview The proposed device is the “Polymer Threaded Anchor” (K983169). The purpose of this submission…
Innovasive Devices, Inc.1996—

Also cleared against K972326: 8 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?

  • 1 of the 2 ancestors has a recall of any class.
  • 8 other devices also cite its predicate K972326.

How does its category compare?

All MBI devices

MBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
2007high 24 (2007) · low 0 (2014)2026

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

Adverse event reports per year · MBI

3,826in 2025

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
2007high 3,826 (2025) · low 240 (2007)2025

MAUDE reports naming product code MBI, 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
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

This device (Polymer Threaded Anchor and Cinch Polymer Threaded Anchor) is intended for use only for the fixation of non-absorbable synthetic sutures. The Polymer Threaded Anchor is intended for the fixation of surgical suture material for the following indications: Shoulder: Bankart lesion repairs SLAP lesion repairs Acromio-clavicular separation repairs Rotator cuff tear repairs Capsular shift or capsulolabral reconstructions Biceps tenodesis Deltoid…

Read the full statement (168 words)

This device (Polymer Threaded Anchor and Cinch Polymer Threaded Anchor) is intended for use only for the fixation of non-absorbable synthetic sutures.

The Polymer Threaded Anchor is intended for the fixation of surgical suture material for the following indications:

Shoulder:

Bankart lesion repairs

SLAP lesion repairs

Acromio-clavicular separation repairs

Rotator cuff tear repairs

Capsular shift or capsulolabral reconstructions

Biceps tenodesis

Deltoid repairs

Foot and Ankle:

Hallux Valgus repairs

Medial or lateral instability repairs/reconstructions

Achilles tendon repairs/reconstructions

Midfoot reconstructions

Metatarsal ligament/tendon repairs/reconstructions

1bow Wrist, and Hand:

Scapholunate ligament reconstructions

Ulnar or radial collateral ligament reconstructions

Tennis elbow repair

Biceps tendon reattachment

Knee:

1. Extra-capsular repairs:

a. medial collateral ligament

b. lateral collateral ligament

c. posterior oblique ligament

2. Hiotibial band tenodesis

3. Pateliar realignment and tendon repairs, including vastus medialis

oblivious advancement

The Cinch Polymer Threaded Anchor is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspensions for female urinary incontinence due to urethral hypermobility of intrinsic sphincter deficiency.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K972326

8 other devices cite the same predicate.

  • K152566PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T…Smith & Nephew, Inc. · 20152 recalls
  • K123425Twinfix TI 3.5MM Suture Anchor with Two Ultrabraid Suture #2 with Needles, SLSmith & Nephew, Inc. · 2013
  • K100159Smith and Nephew Twinfix Ultra TI Suture AnchorSmith & Nephew Inc., Endoscopy Div. · 20104 recalls
  • K083151Extremity Medical Suture AnchorExtremity Medical, LLC · 2009
  • K071520Renovo Suture Anchors, Models 100-2001 Thru 100-5502XCore Essence Orthopaedics, LLC · 2007
  • K053344Bioraptor Suture Anchor, Twinfix 2.8 MM Suture Anchor, Twinfix 3.5 MM Suture AnchorSmith & Nephew, Inc. · 2006

More from Orthopaedic Biosystems, Ltd.

11 FDA decisions under this applicant name. See the company

  • K000797Obl 2.0 MM Mini Tac Anchor, Model 10-1629-01Orthopaedic Biosystems, Ltd. · 2000
  • K982996Polymer Obl SB Anchor / Suture CombinationOrthopaedic Biosystems, Ltd. · 1999
  • K982963Polymer Threaded Anchor / Suture CombinationOrthopaedic Biosystems, Ltd. · 1998
  • K972326Peba Anchor/Suture CombinationOrthopaedic Biosystems, Ltd. · 19981 recall
  • K963420Cancellous Screw WasherOrthopaedic Biosystems, Ltd. · 1996

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K983169 · printed Nov 5, 2026

Cite this page

510(k) Report. “K983169: Polymer Threaded Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983169

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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