510(k) · Cleared

Cleared

Speedfix Suture System

K101437510(k) SpecialCleared Oct 29, 2010158-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

Arthrocare Corp. · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Oct 29, 2010 as substantially equivalent to K090615 (Arthrocare Corp., 2009) after a 158-day review. Its family tree reaches back 4 generations to 1992. 12 later devices descend from it.

Decided: Oct 29, 2010
Review: 158 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 1

Its longest line of descent runs back 4 generations to K921873 (1992). 12 ancestors in all. 12 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 4 generations backK921873 Quickanchor, ModificationMitek Surgical Products, Inc. · 1992
3 generations backK992487 Mitek Mini Quickanchor PlusMitek Products · 1999
2 generations backK061349 Opus Labralock P Knotless Fixation DeviceArthrocare Corp. · 2006
1 generation backK090615 Opus Speedlock Knotless Fixation DeviceArthrocare Corp. · 2009 · Recalled
This deviceK101437 Speedfix Suture SystemArthrocare Corp. · 2010
Descendant · cites it directly · 10 of its ownK112453 Sterispineps Pedicle ScrewSafe Orthopaedics · 2011
Descendant · 2 generations on · 6 of its ownK121299 Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics · 2012
Descendant · 2 generations on · 5 of its ownK130632 Sterispine PS Pedicle ScrewSafe Orthopaedics · 2013
Descendant · 2 generations on · 4 of its ownK150092 STERISPINE PS Pedicle ScrewSafe Orthopaedics · 2015
Descendant · 2 generations on · 4 of its ownK140802 Sterispine PSSafe Orthopaedics · 2014

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2011high 3 (2015) · low 0 (2016)2026

Most influential descendants

Showing 5 of 12 · See all

K112453Sterispineps Pedicle ScrewSafe Orthopaedics · 2011 · cites it directly10descendants
K121299Sterispineps Pedicle Screw, Sterispineps RodSafe Orthopaedics · 2012 · 2 generations on6descendants
K130632Sterispine PS Pedicle ScrewSafe Orthopaedics · 2013 · 2 generations on5descendants
K150092STERISPINE PS Pedicle ScrewSafe Orthopaedics · 2015 · 2 generations on4descendants
K140802Sterispine PSSafe Orthopaedics · 2014 · 2 generations on4descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K921873	Quickanchor, Modification	Mitek Surgical Products, Inc.	1992	—
−3	K992487	Mitek Mini Quickanchor Plus	Mitek Products	1999	—
−2	K061349	Opus Labralock P Knotless Fixation Device	Arthrocare Corp.	2006	—
−1	K090615	Opus Speedlock Knotless Fixation Device	Arthrocare Corp.	2009	1
0 (this device)	K101437	Speedfix Suture System	Arthrocare Corp.	2010	—
+1	K112453	Sterispineps Pedicle Screw	Safe Orthopaedics	2011	—
+2	K121299	Sterispineps Pedicle Screw, Sterispineps Rod	Safe Orthopaedics	2012	—
+2	K130632	Sterispine PS Pedicle Screw	Safe Orthopaedics	2013	—
+2	K150092	STERISPINE PS Pedicle Screw	Safe Orthopaedics	2015	—
+2	K140802	Sterispine PS	Safe Orthopaedics	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1994	1	0
1995	1	0
1997	1	0
2000	1	0
2001	2	0
2004	1	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	2	0
2012	1	0
2013	1	0
2014	1	0
2015	3	0
2017	2	0
2020	1	0
2026	1	0

FIG. 1 — Lineage of K101437, 1992–2026Source: 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
*	K090615	Opus Speedlock Knotless Fixation Device Summary page 1 …ocator Model Name: SpeedLock Drill Guide Generic/Common Name: Drill Guide Predicate Devices Opus® SpeedLock®& K090615 (June 3, 20 10) Knotless Fixation Device Product Description The SpeedFix Suture Implant is a bone anchor that facilitates the a…	Arthrocare Corp.	2009	1

Also cleared against K090615: 1 other device →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K112453	Sterispineps Pedicle Screw	Safe Orthopaedics	2011	10
K111399	Speedfix Suture Implant, 3.0MM Drill, Pathfinder Obturator, Sharp Tipped Obtrurator, Low…	Arthrocare Corp.	2011	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?

The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
3 of the 12 ancestors have a recall of any class.
Of its descendants, K112453 (Safe Orthopaedics, 2011) has gone furthest, with 10 descendants of its own.
1 other device also cites its predicate K090615.

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 SpeedFix Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include: Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction Foot: H-allux valgus reconstruction Elbow…

Read the full statement (90 words)

The SpeedFix Suture Implant is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:

Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair

Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction

Foot: H-allux valgus reconstruction

Elbow: Tennis elbow repair, biceps tendon attachment

Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101437 · printed Nov 6, 2026

Cite this page

510(k) Report. “K101437: Speedfix Suture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101437

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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