510(k) · Cleared

Cleared

Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258

K090075510(k) TraditionalCleared Mar 6, 200953-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

Parcus Medical, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Mar 6, 2009 as substantially equivalent to K003599 (Smith & Nephew, Inc., 2001) and 2 other predicates after a 53-day review. Its family tree reaches back 9 generations to 1991. 13 later devices descend from it.

Decided: Mar 6, 2009
Review: 53 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 3

Its longest line of descent runs back 9 generations to K911837 (1991). 63 ancestors in all, the oldest K792022 (1979). 13 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 9 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
5 generations between
3 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
2 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
1 generation backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
This deviceK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009
Descendant · cites it directly · 7 of its ownK091094 Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC · 2009
Descendant · 2 generations on · 5 of its ownK102326 Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC · 2010
Descendant · cites it directly · 4 of its ownK111000 Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC · 2011
Descendant · cites it directly · 3 of its ownK201083 Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC · 2020
Descendant · 3 generations on · 2 of its ownK132912 Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014 · Recalled

Show all 9 generations

Root · 9 generations backK911837 Suretac Polyglyconate Absorbable Fixation DeviceAcufex Microsurgical, Inc. · 1991
8 generations backK973849 Bioabsorbable Bankart TackHogan & Hartson · 1998
7 generations backK992567 Anatomical Bankart Tack, Model 523520ABionx Implants, Ltd. · 1999
6 generations backK003970 Contour Labral Nail, Model 533520ABionx Implants, Inc. · 2001
5 generations backK020056 Duet Suture AnchorBionx Implants, Ltd. · 2002
4 generations backK030388 Impact Suture Anchor. Model 433510Bionx Implants, Ltd. · 2003
3 generations backK042966 Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor…Linvatec Biomaterials, Ltd. · 2004
2 generations backK053561 Bio-Mini Revo Suture AnchorConmed Linvatec · 2006
1 generation backK072291 Conmed Linvatec Bio Mini-Revo Suture AnchorConmed Linvatec · 2008
This deviceK090075 Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258Parcus Medical, LLC · 2009

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2009high 2 (2010) · low 0 (2012)2026

Most influential descendants

Showing 5 of 13 · See all

K091094Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264Parcus Medical, LLC · 2009 · cites it directly7descendants
K102326Parcus 3.5MM Peek CF Push-in Suture AnchorParcus Medical, LLC · 2010 · 2 generations on5descendants
K111000Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture AnchorParcus Medical, LLC · 2011 · cites it directly4descendants
K201083Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture AnchorsParcus Medical, LLC · 2020 · cites it directly3descendants
K132912Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal ImplantIn2bones Sas · 2014 · 3 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K911837	Suretac Polyglyconate Absorbable Fixation Device	Acufex Microsurgical, Inc.	1991	—
−8	K973849	Bioabsorbable Bankart Tack	Hogan & Hartson	1998	—
−7	K992567	Anatomical Bankart Tack, Model 523520A	Bionx Implants, Ltd.	1999	—
−6	K003970	Contour Labral Nail, Model 533520A	Bionx Implants, Inc.	2001	—
−5	K020056	Duet Suture Anchor	Bionx Implants, Ltd.	2002	—
−4	K030388	Impact Suture Anchor. Model 433510	Bionx Implants, Ltd.	2003	—
−3	K042966	Duet Suture Anchor, Models BXS4216, BXS4216H; Impact Suture Anchor, Models…	Linvatec Biomaterials, Ltd.	2004	—
−2	K053561	Bio-Mini Revo Suture Anchor	Conmed Linvatec	2006	—
−1	K072291	Conmed Linvatec Bio Mini-Revo Suture Anchor	Conmed Linvatec	2008	—
0 (this device)	K090075	Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258	Parcus Medical, LLC	2009	—
+1	K091094	Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264	Parcus Medical, LLC	2009	—
+2	K102326	Parcus 3.5MM Peek CF Push-in Suture Anchor	Parcus Medical, LLC	2010	—
+1	K111000	Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture Anchor	Parcus Medical, LLC	2011	—
+1	K201083	Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors	Parcus Medical, LLC	2020	—
+3	K132912	Duafit Intergphalangeal Implant, Peek-Fuse Interphalangeal Implant	In2bones Sas	2014	2

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1979	1	0
1990	1	0
1993	1	0
1994	2	0
1995	5	0
1996	8	0
1997	10	0
1998	7	0
1999	5	0
2000	3	0
2001	4	0
2002	2	0
2003	1	0
2005	2	0
2006	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	2	0
2011	1	0
2013	1	0
2014	1	0
2015	1	0
2020	1	0
2021	2	0
2022	2	0
2024	1	0

FIG. 1 — Lineage of K090075, 1991–2024Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K003599	Smith & Nephew Suture Anchor Summary page 1 …me: Fastener, Fixation, Non-Degradable, Soft Tissue 21 CFR 888.3040 - Product Code HWC and MBI Predicate Devices: * Smith & Nephew Suture Anchor (K003599) * Arthrex Corkscrew FT IISuture Anchor (K050358) . ConMed Linvatec Bio Mini-Revo Suture Anchor (K072291) Device Description…	Smith & Nephew, Inc.	2001	—
*	K050358	Artherx Corkscrew FT II Suture Anchor Summary page 1 …21 CFR 888.3040 - Product Code HWC and MBI Predicate Devices: * Smith & Nephew Suture Anchor (K003599) * Arthrex Corkscrew FT IISuture Anchor (K050358) . ConMed Linvatec Bio Mini-Revo Suture Anchor (K072291) Device Description: The Parcus V-LoX Titanium Suture Anchor is a thre…	Arthrex, Inc.	2005	—
*	K072291	Conmed Linvatec Bio Mini-Revo Suture Anchor Summary page 1 …nd MBI Predicate Devices: * Smith & Nephew Suture Anchor (K003599) * Arthrex Corkscrew FT IISuture Anchor (K050358) . ConMed Linvatec Bio Mini-Revo Suture Anchor (K072291) Device Description: The Parcus V-LoX Titanium Suture Anchor is a threaded, tapered fastener for use in attachment of soft tissu…	Conmed Linvatec	2008	—

What descends from it? (13)

See all 13

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

Number	Device	Applicant	Decided	Descendants
K091094	Parcus V-Lox Peek CF Suture Anchor, Models: 10253, 10254, 10263, 10264	Parcus Medical, LLC	2009	7
K111000	Parcus 2.0MM / 2.5MM / 3.5MM Miti Titanium Suture Anchor	Parcus Medical, LLC	2011	4
K201083	Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors	Parcus Medical, LLC	2020	3

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 7 companies; a new generation was cleared every 1.5 years on median.
6 of the 63 ancestors have a recall of any class.
Of its descendants, K091094 (Parcus Medical, LLC, 2009) has gone furthest, with 7 descendants of its own.

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. 2009, 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 Parcus V-LoXTM Titanium Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair. Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair…

Read the full statement (108 words)

The Parcus V-LoXTM Titanium Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Shoulder Rotator Cuff Repair, Acromioclavicular Separation Repair, Bankart Lesion Repair, Biceps Tenodesis, Capsular Shift or Capsulolabral Reconstruction, Deltoid Repair, SLAP Lesion Repair.

Knee Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Extra Capsular Reconstruction, Iliotibial Band Tenodesis, Patellar Ligament and Tendon Avulsion Repair.

Foot/Ankle Lateral Stabilization, Medial Stabilization, Midfoot Reconstruction, Achilles Tendon Repair, Hallux Valgus Reconstruction, Metatarsal Ligament Repair.

Elbow Tennis Elbow Repair, Biceps Tendon Reattachment.

Hand/Wrist Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, TFCC.

Hip Acetabular Labral Repair

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K090075 · printed Nov 4, 2026

Cite this page

510(k) Report. “K090075: Parcus V-Lox Titanium Suture Anchor,Models: 10251, 10252, 10257, 10258.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090075

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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