510(k) · Cleared
ClearedParcus Knotless PEEK and PEEK CF Push-In Suture Anchor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parcus Medical, LLC · MBI Fastener, Fixation, Nondegradable, Soft Tissue
Cleared on Jan 23, 2020 as substantially equivalent to K113730 (Parcus Medical, LLC, 2012) after a 57-day review. Its family tree reaches back 1 generation to 2012. 5 later devices descend from it.
- Decided
- Jan 23, 2020
- Review
- 57 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K113730 (2012). 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK113730 Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45…Parcus Medical, LLC · 2012
- This deviceK193295 Parcus Knotless PEEK and PEEK CF Push-In Suture AnchorParcus Medical, LLC · 2020
- Descendant · cites it directly · 2 of its ownK200503 ATL AnchorsInternational Life Sciences · 2020 · Recalled
- Descendant · cites it directly · 1 of its ownK212381 VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021
- Descendant · 2 generations on · 0 of its ownK260317 Artelon Convenience KitsInternational Life Sciences · 2026
- Descendant · 2 generations on · 0 of its ownK253538 TeKBrace Knotless AnchorTheramicro · 2026
- Descendant · 2 generations on · 0 of its ownK242296 VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002)…Ortho-Design (Pty), Ltd. · 2024
Most influential descendants
Showing 5 of 5 · See all- K200503ATL AnchorsInternational Life Sciences · 2020 · cites it directly2descendants
- K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021 · cites it directly1descendant
- K260317Artelon Convenience KitsInternational Life Sciences · 2026 · 2 generations on0descendants
- K253538TeKBrace Knotless AnchorTheramicro · 2026 · 2 generations on0descendants
- K242296VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™ Suture…Ortho-Design (Pty), Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K113730 | Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF… | Parcus Medical, LLC | 2012 | — |
| 0 (this device) | K193295 | Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor | Parcus Medical, LLC | 2020 | — |
| +1 | K200503 | ATL Anchors | International Life Sciences | 2020 | 2 |
| +1 | K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | Ortho-Design (Pty), Ltd. | 2021 | — |
| +2 | K260317 | Artelon Convenience Kits | International Life Sciences | 2026 | — |
| +2 | K253538 | TeKBrace Knotless Anchor | Theramicro | 2026 | — |
| +2 | K242296 | VersaTap™ Suture Anchor (ADP050); VersaPEEK™ Suture Anchor (APP002); MicroTi™… | Ortho-Design (Pty), Ltd. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 2 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K113730 | Parcus 35 Knotless Peek CF Push-in Suture Anchors, Parcus 45 Knotless Peek CF Push-in…Summary page 4…Class II Classification Name: 21 CFR 888.3040 - Product Code MBI Predicate Device: Parcus Knotless PEEK CF Suture Anchors, K113730, cleared 1/17/2012 Reference Devices: Parcus Twist PEEK Suture A… | 2012 |
| † | K120942 | Parcus Twist 4 5MM Peek Suture Anchor, Parcus Twist 5.5MM Peek Suture Anchor & Parcus… | 2012 |
| † | K170327 | Parcus SLiK Anchors | 2017 |
| † | K170877 | Parcus SLiK Fix Screw | 2017 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All MBI devicesMBI Fastener, Fixation, Nondegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · MBI
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MBI
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MBI
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MBI
3,826in 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 Knotless PEEK and 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, 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…
Read the full statement (112 words)
The Parcus Knotless PEEK and 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, 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/K193295 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193295: Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193295
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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