510(k) Report

510(k) · Cleared

Cleared

Polymer Threaded Anchor / Suture Combination

K982963510(k) TraditionalCleared Nov 20, 199888-day reviewClass II21 CFR 888.3350

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

Orthopaedic Biosystems, Ltd. · JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Cleared on Nov 20, 1998 as substantially equivalent to K972326 (Orthopaedic Biosystems, Ltd., 1998) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1996. 4 later devices descend from it.

Decided
Nov 20, 1998
Review
88 days
Class
Class II
Product code
JDI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K963402 (1996). 2 ancestors in all. 4 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor2001: 1 descendant cleared2004: 1 descendant cleared2006: 2 descendants clearedK963402 · Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener · Innovasive Devices, Inc. · 19961995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 1 descendant 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 deviceK982963 Polymer Threaded Anchor / Suture CombinationOrthopaedic Biosystems, Ltd. · 1998
  3. Descendant · cites it directly · 3 of its ownK011985 Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc. · 2001
  4. Descendant · 2 generations on · 1 of its ownK042038 MTF Allograft AnchorMusculoskeletal Transplant Foundation · 2004
  5. Descendant · 2 generations on · 0 of its ownK061498 Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation · 2006 · Recalled
  6. Descendant · 3 generations on · 0 of its ownK053339 Allofix AnchorMusculoskeletal Transplant Foundation · 2006

Most influential descendants

Showing 4 of 4 · See all
  • K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc. · 2001 · cites it directly3descendants
  • K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation · 2004 · 2 generations on1descendant
  • K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation · 2006 · 2 generations on0descendants
  • K053339Allofix AnchorMusculoskeletal Transplant Foundation · 2006 · 3 generations on0descendants
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)K982963Polymer Threaded Anchor / Suture CombinationOrthopaedic Biosystems, Ltd.1998—
+1K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc.2001—
+2K042038MTF Allograft AnchorMusculoskeletal Transplant Foundation2004—
+2K061498Allofix Anchor, 5.0 MM AnchorMusculoskeletal Transplant Foundation20061
+3K053339Allofix AnchorMusculoskeletal Transplant Foundation2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200410
200620
FIG. 1 — Lineage of K982963, 1996–2006Source: 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 JDI? 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 JDI device

  1. #1 K253515 Zimmer Biomet OSS™ Orthopedic Salvage System…score 15.2 · 12 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
…ymer Threaded Anchor/Suture Combination” (K982963). 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/Suture Combination”. Changing the material used for the implant requires a…
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: verview The proposed device is the “Polymer Threaded Anchor/Suture Combination” (K982963). The purpose o…
Innovasive Devices, Inc.1996—

Also cleared against K972326: 8 other devices →

What descends from it? (4)

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

NumberDeviceApplicantDecidedDescendants
K011985Smith & Nephew Phoenix 5.0 Allograft Anchor KitSmith & Nephew, Inc.20013

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.
  • Of its descendants, K011985 (Smith & Nephew, Inc., 2001) has gone furthest, with 3 descendants of its own.
  • 8 other devices also cite its predicate K972326.

How does its category compare?

All JDI devices

JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDI

1in 2025

2007: 32008: 52009: 32011: 22012: 42013: 32014: 32015: 32016: 42017: 12018: 12019: 22020: 72021: 32022: 32023: 22024: 32025: 12026 (partial year): 2
2007high 7 (2020) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDI

59in 2024

2007: 81 days median2008: 96 days median2009: 65 days median2012: 167 days median2013: 176 days median2014: 98 days median2015: 190 days median2016: 166 days median2020: 247 days median2021: 162 days median2022: 69 days median2024: 59 days median
2007high 247 (2020) · low 59 (2024)2026

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

Recalls per year · JDI

1in 2025

2007: 262008: 62009: 32010: 32011: 52012: 42013: 112014: 32015: 12016: 52017: 52018: 12019: 12020: 772025: 1
2007high 77 (2020) · low 0 (2021)2026

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

Adverse event reports per year · JDI

1,644in 2025

2007: 6962008: 8102009: 9642010: 2,0402011: 3,1602012: 5,1222013: 5,2062014: 4,9682015: 4,9062016: 3,9952017: 6,1352018: 6,7282019: 7,4072020: 4,0152021: 3,1702022: 1,9782023: 1,6352024: 1,8212025: 1,644
2007high 7,407 (2019) · low 696 (2007)2025

MAUDE reports naming product code JDI, 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
200738126696
20085966810
20093653964
20100—32,040
20112—53,160
2012416745,122
20133176115,206
201439834,968
2015319014,906
2016416653,995
20171—56,135
20181—16,728
20192—17,407
20207247774,015
2021316203,170
202236901,978
20232—01,635
202435901,821
20251—11,644
20262—0—

What is it indicated for?

This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures. The PeBA Series Anchor/Suture Combination 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…

Read the full statement (186 words)

This device (PeBA Series and Cinch Series Anchor/Suture Combination) is intended for use only for the fixation of non-absorbable synthetic sutures.

The PeBA Series Anchor/Suture Combination 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

Elbow, Wrist, and Hand:

Scapholunate ligament reconstructions

Ulnar or radial collateral ligament reconstructions

Tennis elbow repair

Biceps tendon reattachment

Extra-capsular repairs:

a. medial collateral ligament

b. lateral collateral ligament

c. posterior oblique ligament

Iliotibial band tenodesis

Patellar realignment and tendon repairs, including vastus medialis obliquus advancement

The Cinch Threaded Anchor/Suture Combination 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. The Cinch Threaded Anchor/Suture Combination is intended for the fixation of surgical suture material for the following indication:

Urinary: Bladder Neck Suspension

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
  • K983169Polymer Threaded AnchorOrthopaedic Biosystems, Ltd. · 1998
  • K972326Peba Anchor/Suture CombinationOrthopaedic Biosystems, Ltd. · 19981 recall
  • K963420Cancellous Screw WasherOrthopaedic Biosystems, Ltd. · 1996

Recent decisions in JDI

The JDI category page

  • K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc. · 2026
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  • K240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip…Smith & Nephew, Inc. · 2024
  • K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker Orthopaedics · 2024

https://510kreport.com/device/K982963 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982963: Polymer Threaded Anchor / Suture Combination.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982963

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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