510(k) · Cleared

Cleared

G-Force Peek Suture Anchor System

K100630510(k) TraditionalCleared Jun 11, 201098-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

Wrightmedicaltechnologyinc · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Jun 11, 2010 as substantially equivalent to K971282 (Wrightmedicaltechnologyinc, 1997) after a 98-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Jun 11, 2010
Review: 98 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K971282 (1997). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK971282 Anchorlok and Anchorlok RL Soft Tissue Anchor SystemWrightmedicaltechnologyinc · 1997 · Recalled
This deviceK100630 G-Force Peek Suture Anchor SystemWrightmedicaltechnologyinc · 2010
Descendant · cites it directly · 0 of its ownK170265 GRAVITYTM PEEK-OPTIMA Suture AnchorWrightmedicaltechnologyinc · 2017

Most influential descendants

Showing 1 of 1 · See all

K170265GRAVITYTM PEEK-OPTIMA Suture AnchorWrightmedicaltechnologyinc · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K971282	Anchorlok and Anchorlok RL Soft Tissue Anchor System	Wrightmedicaltechnologyinc	1997	10
0 (this device)	K100630	G-Force Peek Suture Anchor System	Wrightmedicaltechnologyinc	2010	—
+1	K170265	GRAVITYTM PEEK-OPTIMA Suture Anchor	Wrightmedicaltechnologyinc	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K100630, 1997–2017Source: 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 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 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

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
*	K971282	Anchorlok and Anchorlok RL Soft Tissue Anchor System Summary page 1 …edicate Device: ANCHORLOK® Soft Tissue Anchor System (K971282) DEVICE INFORMATION A. DEVICE DESCRIPTION The G-FORCE® Suture Anchor is a sterile, sing…	Wrightmedicaltechnologyinc	1997	10

Also cleared against K971282: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K170265	GRAVITYTM PEEK-OPTIMA Suture Anchor	Wrightmedicaltechnologyinc	2017	0

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?

Its one ancestor has a recall.
Of its descendants, K170265 (Wrightmedicaltechnologyinc, 2017) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K971282.

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. 2010, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	16	80	24	240
2008	10	69	6	338
2009	19	82	2	355
2010	17	76	3	291
2011	30	75	23	328
2012	24	94	6	371
2013	31	100	2	442
2014	23	101	0	504
2015	23	85	0	507
2016	17	94	0	795
2017	17	70	4	675
2018	16	91	2	1,072
2019	31	90	0	1,303
2020	35	83	1	1,454
2021	18	107	0	1,890
2022	19	64	0	1,591
2023	52	57	1	2,503
2024	22	30	1	3,779
2025	27	58	1	3,826
2026	30	63	0	—

What is it indicated for?

The G-FORCE® Suture Anchor System is indicated for use: * In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction; * In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation; * In the repair of hand/wrist…

Read the full statement (141 words)

The G-FORCE® Suture Anchor System is indicated for use:

* In the repair of shoulder instability secondary to Bankart lesion, rotator cuff tear, a slap lesion, acromioclavicular separation, biceps tenodesis, deltoid tear/separation, or capsular shift or capsulolabral reconstruction;

* In the repair of elbow instability secondary to biceps tendon detachment, tennis elbow, or ulnar or radial collateral ligament tear/separation;

* In the repair of hand/wrist instability secondary to tear or separation of the scapholunate ligament, ulnar collateral ligament, or radial collateral ligament;

* In the repair of knee instability secondary to tear or separation of the medial collateral ligament, lateral collateral ligament, patellar tendon, or posterior oblique ligament, or secondary to iliotibial band tenodesis;

* In the repair of foot/ankle instability secondary to tear or separation of the Achilles tendon, lateral stabilization tendons/ligaments, medial stabilization tendons/ligaments, midfoot tendons/ligaments, or metatarsal tendons/ligaments.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K100630 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100630: G-Force Peek Suture Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100630

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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