510(k) Report

510(k) · Cleared

Cleared

Parcus SLiK Anchors

K170327510(k) TraditionalCleared Mar 30, 201756-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 · MBI Fastener, Fixation, Nondegradable, Soft Tissue

Cleared on Mar 30, 2017 as substantially equivalent to K113730 (Parcus Medical, LLC, 2012) and 1 other predicate after a 56-day review. Its family tree reaches back 1 generation to 2012. 5 later devices descend from it.

Decided
Mar 30, 2017
Review
56 days
Class
Class II
Product code
MBI
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K113730 (2012). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2012: 1 other ancestor2022: 2 descendants cleared2023: 1 descendant cleared2025: 1 descendant cleared2026: 1 descendant clearedK113730 · Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF Push-in Suture Anchors · Parcus Medical, LLC · 20122010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 1 descendant K113730 · Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF Push-in Suture Anchors · Parcus Medical, LLC · 20120
  1. Root · 1 generation backK113730 Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45…Parcus Medical, LLC · 2012
  2. This deviceK170327 Parcus SLiK AnchorsParcus Medical · 2017
  3. Descendant · cites it directly · 3 of its ownK221135 X-Twist PEEK Suture AnchorParcus Medical, LLC · 2022
  4. Descendant · 2 generations on · 1 of its ownK243712 WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025
  5. Descendant · 3 generations on · 0 of its ownK253618 QuadLock™ Fixation SystemAbanza Tecnomed S.L · 2026
  6. Descendant · 2 generations on · 0 of its ownK232513 X-Twist Biocomposite Suture AnchorParcus Medical · 2023
  7. Descendant · cites it directly · 0 of its ownK213110 AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK…Auxein Medical Private Limited · 2022

Most influential descendants

Showing 5 of 5 · See all
  • K221135X-Twist PEEK Suture AnchorParcus Medical, LLC · 2022 · cites it directly3descendants
  • K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025 · 2 generations on1descendant
  • K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L · 2026 · 3 generations on0descendants
  • K232513X-Twist Biocomposite Suture AnchorParcus Medical · 2023 · 2 generations on0descendants
  • K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorAuxein Medical Private Limited · 2022 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K113730Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF…Parcus Medical, LLC2012—
0 (this device)K170327Parcus SLiK AnchorsParcus Medical2017—
+1K221135X-Twist PEEK Suture AnchorParcus Medical, LLC2022—
+2K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L2025—
+3K253618QuadLock™ Fixation SystemAbanza Tecnomed S.L2026—
+2K232513X-Twist Biocomposite Suture AnchorParcus Medical2023—
+1K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA…Auxein Medical Private Limited2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202220
202310
202510
202610
FIG. 1 — Lineage of K170327, 2012–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203268 Arthrex FiberTak Suture Anchorscore 21.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K113730Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF Push-in…
Summary page 4
…n, Non-Degradable, Soft Tissue 21 CFR 888.3040 - Product Code MBI Predicate Device: The predicate devices are the Parcus 35/45 Knotless PEEK CF Push-In Suture Anchors (K113730, cleared 1/17/12) and the Parcus Twist PEEK Suture Anchors (K120942, cleared 4/20/12). Device Description: The Parcus SLiK Anch…
Parcus Medical, LLC2012—
*K120942Parcus Twist 4 5MM Peek Suture Anchor, Parcus Twist 5.5MM Peek Suture Anchor & Parcus…
Summary page 4
…Predicate Device: The predicate devices are the Parcus 35/45 Knotless PEEK CF Push-In Suture Anchors (K113730, cleared 1/17/12) and the Parcus Twist PEEK Suture Anchors (K120942, cleared 4/20/12). Device Description: The Parcus SLiK Anchors are designed for use in the attachment of soft tissue to bone. T…
Parcus Medical, LLC2012—

Also cleared against K113730: 2 other devices →

What descends from it? (5)

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

NumberDeviceApplicantDecidedDescendants
K221135X-Twist PEEK Suture AnchorParcus Medical, LLC20223
K213110AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In AnchorAuxein Medical Private Limited20220

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.
  • Of its descendants, K221135 (Parcus Medical, LLC, 2022) has gone furthest, with 3 descendants of its own.
  • 2 other devices also cite its predicate K113730.

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. 2017, this device’s year, is highlighted.

FDA decisions per year · MBI

27in 2025

2007: 162008: 102009: 192010: 172011: 302012: 242013: 312014: 232015: 232016: 172017: 172018: 162019: 312020: 352021: 182022: 192023: 522024: 222025: 272026 (partial year): 30
2007high 52 (2023) · low 10 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MBI

58in 2025

2007: 80 days median2008: 69 days median2009: 82 days median2010: 76 days median2011: 75 days median2012: 94 days median2013: 100 days median2014: 101 days median2015: 85 days median2016: 94 days median2017: 70 days median2018: 91 days median2019: 90 days median2020: 83 days median2021: 107 days median2022: 64 days median2023: 57 days median2024: 30 days median2025: 58 days median2026 (partial year): 63 days median
2007high 107 (2021) · low 30 (2024)2026

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

Recalls per year · MBI

1in 2025

2007: 242008: 62009: 22010: 32011: 232012: 62013: 22017: 42018: 22020: 12023: 12024: 12025: 1
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

2007: 2402008: 3382009: 3552010: 2912011: 3282012: 3712013: 4422014: 5042015: 5072016: 7952017: 6752018: 1,0722019: 1,3032020: 1,4542021: 1,8902022: 1,5912023: 2,5032024: 3,7792025: 3,826
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007168024240
200810696338
200919822355
201017763291
2011307523328
201224946371
2013311002442
2014231010504
201523850507
201617940795
201717704675
2018169121,072
2019319001,303
2020358311,454
20211810701,890
2022196401,591
2023525712,503
2024223013,779
2025275813,826
202630630—

What is it indicated for?

The Parcus SLiK 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…

Read the full statement (102 words)

The Parcus SLiK 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.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K113730

2 other devices cite the same predicate.

  • K193295Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorParcus Medical, LLC · 2020
  • K170877Parcus SLiK Fix ScrewParcus Medical · 2017

More from Parcus Medical

3 FDA decisions under this applicant name. See the company

  • K232513X-Twist Biocomposite Suture AnchorParcus Medical · 2023
  • K170877Parcus SLiK Fix ScrewParcus Medical · 2017

Recent decisions in MBI

The MBI category page

  • K263348Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor…Smith & Nephew, Inc. · 2026
  • K263352TeKBrace Knotless AnchorTheraMicro · 2026
  • K261869Integrity Retractable Implant Inserter (6000127)Anika Therapeutics, Inc. · 2026
  • K253065Aevumed SUPERCYNCH™ Button SystemAevumed, Inc. · 2026
  • K262809ArthroTAK Tendon Anchor KitArthroTAK, LLC · 2026

https://510kreport.com/device/K170327 · printed Nov 6, 2026

Cite this page

510(k) Report. “K170327: Parcus SLiK Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170327

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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