510(k) · Cleared
ClearedParcus Twist AP Suture Anchors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parcus Medical, LLC · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Mar 15, 2019 as substantially equivalent to K120942 (Parcus Medical, LLC, 2012) and 3 other predicates after an 88-day review. Its family tree reaches back 9 generations to 1997. 2 later devices descend from it.
- Decided
- Mar 15, 2019
- Review
- 88 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K971358 (1997). 32 ancestors in all, the oldest K961555 (1996). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 5 generations between
- 3 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- 2 generations backK112249 Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011
- 1 generation backK130917 Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2013 · Recalled
- This deviceK183501 Parcus Twist AP Suture AnchorsParcus Medical, LLC · 2019
- Descendant · cites it directly · 0 of its ownK232513 X-Twist Biocomposite Suture AnchorParcus Medical · 2023
- Descendant · cites it directly · 0 of its ownK192824 Parcus Knotless AP Suture AnchorsParcus Medical, LLC · 2019
Show all 9 generations
- Root · 9 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 8 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 7 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 6 generations backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- 5 generations backK032717 Biocryl Rapide Interference ScrewMitek Worldwide · 2004
- 4 generations backK060830 Milagro Interference ScrewDepuy Mitek, A Johnson & Johnson Company · 2006
- 3 generations backK073412 Gryphon BR and Healix BR AnchorsDepuy Mitek, A Johnson & Johnson Company · 2008 · Recalled
- 2 generations backK112249 Healix Knotless (TM) AnchorDepuy Mitek, A Johnson & Johnson Company · 2011
- 1 generation backK130917 Healix Advance Knotless BR AnchorDepuy Mitek, A Johnson & Johnson Company · 2013 · Recalled
- This deviceK183501 Parcus Twist AP Suture AnchorsParcus Medical, LLC · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −8 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −7 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −6 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| −5 | K032717 | Biocryl Rapide Interference Screw | Mitek Worldwide | 2004 | — |
| −4 | K060830 | Milagro Interference Screw | Depuy Mitek, A Johnson & Johnson Company | 2006 | — |
| −3 | K073412 | Gryphon BR and Healix BR Anchors | Depuy Mitek, A Johnson & Johnson Company | 2008 | 1 |
| −2 | K112249 | Healix Knotless (TM) Anchor | Depuy Mitek, A Johnson & Johnson Company | 2011 | — |
| −1 | K130917 | Healix Advance Knotless BR Anchor | Depuy Mitek, A Johnson & Johnson Company | 2013 | 2 |
| 0 (this device) | K183501 | Parcus Twist AP Suture Anchors | Parcus Medical, LLC | 2019 | — |
| +1 | K232513 | X-Twist Biocomposite Suture Anchor | Parcus Medical | 2023 | — |
| +1 | K192824 | Parcus Knotless AP Suture Anchors | Parcus Medical, LLC | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 4 | 0 |
| 2007 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2023 | 1 | 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 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? (4)
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 |
|---|---|---|---|
| * | K120942 | Parcus Twist 4 5MM Peek Suture Anchor, Parcus Twist 5.5MM Peek Suture Anchor & Parcus…Summary page 4…888.3030 - Product Code MAI Predicate Device: The predicate devices are the: • Parcus Medical Twist PEEK Suture Anchor (K120942 cleared April 20th, 2012), • DePuy Mitek HEALIX BR Anchor (K073412 cl… | 2012 |
| * | K073412 | Gryphon BR and Healix BR AnchorsSummary page 4…Parcus Medical Twist PEEK Suture Anchor (K120942 cleared April 20th, 2012), • DePuy Mitek HEALIX BR Anchor (K073412 cleared January 17th, 2008), • DePuy Mitek Healix Knotless BR (K13091… | 2008 |
| * | K130917 | Healix Advance Knotless BR AnchorSummary page 4…• DePuy Mitek HEALIX BR Anchor (K073412 cleared January 17th, 2008), • DePuy Mitek Healix Knotless BR (K130917 cleared May 24th, 2013), and • DePuy Mitek Lupine BR Anchor (K070925… | 2013 |
| * | K070925 | Modification to: Bioknotless BR Anchor / Lupine BR AnchorSummary page 4…• DePuy Mitek Healix Knotless BR (K130917 cleared May 24th, 2013), and • DePuy Mitek Lupine BR Anchor (K070925 cleared May 2nd, 2007). Device Description: The Parcus Twist AP Suture Anchors consist… | 2007 |
What descends from it? (2)
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?
- The line of descent spans 22 years and passes through 6 companies; a new generation was cleared every 2.0 years on median.
- 10 of the 32 ancestors have a recall of any class.
- Of its descendants, K232513 (Parcus Medical, 2023) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K120942.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The Parcus Twist AP Suture Anchors are indicated for the 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…
Read the full statement (105 words)
The Parcus Twist AP Suture Anchors are indicated for the 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.
https://510kreport.com/device/K183501 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183501: Parcus Twist AP Suture Anchors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183501
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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