510(k) · Cleared

Cleared

Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF Push-in Suture Anchors

K113730510(k) SpecialCleared Jan 17, 201229-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 Jan 17, 2012 after a 29-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 14 later devices descend from it.

Decided: Jan 17, 2012
Review: 29 days
Class: Class II
Product code: MBI
Recalls: None
Predicates: 0

14 later devices descend from it, 3 citing it directly.

This deviceK113730 Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45…Parcus Medical, LLC · 2012
Descendant · cites it directly · 5 of its ownK193295 Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorParcus Medical, LLC · 2020
Descendant · cites it directly · 5 of its ownK170327 Parcus SLiK AnchorsParcus Medical · 2017
Descendant · 2 generations on · 3 of its ownK221135 X-Twist PEEK Suture AnchorParcus Medical, LLC · 2022
Descendant · 2 generations on · 2 of its ownK200503 ATL AnchorsInternational Life Sciences · 2020 · Recalled
Descendant · 3 generations on · 1 of its ownK243712 WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2017high 3 (2020) · low 0 (2018)2026

Most influential descendants

Showing 5 of 14 · See all

K193295Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorParcus Medical, LLC · 2020 · cites it directly5descendants
K170327Parcus SLiK AnchorsParcus Medical · 2017 · cites it directly5descendants
K221135X-Twist PEEK Suture AnchorParcus Medical, LLC · 2022 · 2 generations on3descendants
K200503ATL AnchorsInternational Life Sciences · 2020 · 2 generations on2descendants
K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K113730	Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF…	Parcus Medical, LLC	2012	—
+1	K193295	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	Parcus Medical, LLC	2020	—
+1	K170327	Parcus SLiK Anchors	Parcus Medical	2017	—
+2	K221135	X-Twist PEEK Suture Anchor	Parcus Medical, LLC	2022	—
+2	K200503	ATL Anchors	International Life Sciences	2020	2
+3	K243712	WasherCap™ Mini Fixation System (Model 45)	Abanza Tecnomed S.L	2025	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	2	0
2020	3	0
2021	1	0
2022	2	0
2023	1	0
2024	1	0
2025	1	0
2026	3	0

FIG. 1 — Lineage of K113730, 2012–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (14)

See all 14

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

Number	Device	Applicant	Decided	Descendants
K193295	Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor	Parcus Medical, LLC	2020	5
K170327	Parcus SLiK Anchors	Parcus Medical	2017	5
K170877	Parcus SLiK Fix Screw	Parcus Medical	2017	1

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?

Of its descendants, K193295 (Parcus Medical, LLC, 2020) has gone furthest, with 5 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. 2012, 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 PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications: Shoulder: Rotator Cuff Repair, Acromnioclavicular 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 (114 words)

The Parcus PEEK CF Push-In Suture Anchors are indicated for attachment of soft tissue to bone. This product is intended for the following indications:

Shoulder: Rotator Cuff Repair, Acromnioclavicular 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 (35 and 45 Knotless only)

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K113730 · printed Nov 6, 2026

Cite this page

510(k) Report. “K113730: Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF Push-in Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113730

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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