510(k) · Cleared

Cleared

Polymer Obl SB Anchor / Suture Combination

K982996510(k) TraditionalCleared Mar 4, 1999189-day reviewClass II21 CFR 888.3030

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

Orthopaedic Biosystems, Ltd. · JDR Staple, Fixation, Bone

Cleared on Mar 4, 1999 as substantially equivalent to K963402 (Innovasive Devices, Inc., 1996) and 1 other predicate after a 189-day review. Its family tree reaches back 1 generation to 1995.

Decided: Mar 4, 1999
Review: 189 days
Class: Class II
Product code: JDR
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K950592 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK950592 Accessories Foe Orthopedic Surgical ProceduresEare Consulting Service · 1995
This deviceK982996 Polymer Obl SB Anchor / Suture CombinationOrthopaedic Biosystems, Ltd. · 1999

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K950592	Accessories Foe Orthopedic Surgical Procedures	Eare Consulting Service	1995	—
0 (this device)	K982996	Polymer Obl SB Anchor / Suture Combination	Orthopaedic Biosystems, Ltd.	1999	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K982996, 1995–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 JDR? 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 JDR device

#1 K243658 TMC Compression Implant Systemscore 16.7 · 18 generations · no Class I recall
#2 Held for the reportin the report
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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K963402	Innovasive 2.8MM Roc Suture Bone Fastener and 3.5MM Roc Suture Bone Fastener Summary page 1 …uture Combination has features substantially equivalent to two 510(k) approved devices. These include: - “2.8 and 3.5mm ROC Suture Bone Fastener” by Innovasive Devices (K963402). - “SB Bone Anchor” by Orthopaedic Biosystems Ltd., Inc (K950592) DEVICE DESCRIPTION: The Polymer OBL SB Anchor is a simple mo…	Innovasive Devices, Inc.	1996	—
*	K950592	Accessories Foe Orthopedic Surgical Procedures Summary page 1 …(k) approved devices. These include: - “2.8 and 3.5mm ROC Suture Bone Fastener” by Innovasive Devices (K963402). - “SB Bone Anchor” by Orthopaedic Biosystems Ltd., Inc (K950592) DEVICE DESCRIPTION: The Polymer OBL SB Anchor is a simple modified polyacetal cylinder designed to be pushed through a hole in…	Eare Consulting Service	1995	—

Also cleared against K963402: 3 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?

None of the 2 ancestors has a recall.
3 other devices also cite its predicate K963402.

How does its category compare?

All JDR devices

JDR Staple, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JDR

3in 2025

2007high 11 (2014) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JDR

65in 2025

2007high 172 (2017) · low 29 (2024)2026

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

Recalls per year · JDR

11in 2022

2007high 11 (2022) · low 0 (2007)2026

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

Adverse event reports per year · JDR

314in 2025

2007high 314 (2025) · low 3 (2007)2025

MAUDE reports naming product code JDR, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	8	70	0	3
2008	5	89	1	14
2009	0	—	0	10
2010	2	—	0	35
2011	1	—	0	62
2012	1	—	0	34
2013	9	137	0	27
2014	11	97	0	49
2015	7	111	1	48
2016	6	101	0	76
2017	9	172	0	116
2018	8	107	1	239
2019	5	149	0	242
2020	4	161	1	234
2021	3	62	0	210
2022	5	107	11	202
2023	9	72	0	175
2024	4	29	0	206
2025	3	65	0	314
2026	2	—	2	—

What is it indicated for?

This device, Polymer OBL SB Series and Cinch Series Anchor/Suture Combination is intended for use only for the fixation of non-absorbable synthetic sutures for the following indications. The Polymer Cinch SB 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.…

Read the full statement (160 words)

This device, Polymer OBL SB Series and Cinch Series Anchor/Suture Combination is intended

for use only for the fixation of non-absorbable synthetic sutures for the following indications.

The Polymer Cinch SB 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.

Shoulder:

1. Bankhart Repair

2. SLAP Lesion Repair

3. Acromio-clavicular separation

4. Rotator Cuff Repair

S. Capsule and Capsulolabral Reconstruction

6. Biceps Tenodesis

7. Deltoid Repair

Hand, Wrist, Elbow:

1. Scapholunate ligament reconstruction

2. Ulnar Collateral Ligament Reconstruction

3. Lateral Collateral Ligament Reconstruction

4. Biceps Tendon Reattachment

5. Elbow Medial/Lateral Repair of Tendons in the Elbow

Foot:

1. Hallux Valgus Reconstruction

2. Mid and Forefoot Reconstruction

Knee:

1. medial collateral ligament

2. Jateral collateral ligament

3. posterior oblique ligament b

4. Joint capsule closure

5. Iitiotibial band tendonesis

6. VMO Advancement

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.

https://510kreport.com/device/K982996 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982996: Polymer Obl SB 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/K982996

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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