510(k) · Cleared
ClearedParcus Twist 4 5MM Peek Suture Anchor, Parcus Twist 5.5MM Peek Suture Anchor & Parcus Triple Twist 5.5MM Peek Suture Anc
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 Apr 20, 2012 after a 22-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 14 later devices descend from it.
- Decided
- Apr 20, 2012
- Review
- 22 days
- Class
- Class II
- Product code
- MBI
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 6 citing it directly.
- This deviceK120942 Parcus Twist 4 5MM Peek Suture Anchor, Parcus Twist 5.5MM Peek…Parcus Medical, LLC · 2012
- Descendant · cites it directly · 5 of its ownK170327 Parcus SLiK AnchorsParcus Medical · 2017
- Descendant · cites it directly · 3 of its ownK221135 X-Twist PEEK Suture AnchorParcus Medical, LLC · 2022
- Descendant · cites it directly · 2 of its ownK183501 Parcus Twist AP Suture AnchorsParcus Medical, LLC · 2019
- Descendant · 2 generations on · 1 of its ownK243712 WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025
- Descendant · cites it directly · 1 of its ownK212381 VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K170327Parcus SLiK AnchorsParcus Medical · 2017 · cites it directly5descendants
- K221135X-Twist PEEK Suture AnchorParcus Medical, LLC · 2022 · cites it directly3descendants
- K183501Parcus Twist AP Suture AnchorsParcus Medical, LLC · 2019 · cites it directly2descendants
- K243712WasherCap™ Mini Fixation System (Model 45)Abanza Tecnomed S.L · 2025 · 2 generations on1descendant
- K212381VersaTap, VersaLat, DueLock, VersaTi, MiniTiOrtho-Design (Pty), Ltd. · 2021 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K120942 | Parcus Twist 4 5MM Peek Suture Anchor, Parcus Twist 5.5MM Peek Suture Anchor &… | Parcus Medical, LLC | 2012 | — |
| +1 | K170327 | Parcus SLiK Anchors | Parcus Medical | 2017 | — |
| +1 | K221135 | X-Twist PEEK Suture Anchor | Parcus Medical, LLC | 2022 | — |
| +1 | K183501 | Parcus Twist AP Suture Anchors | Parcus Medical, LLC | 2019 | — |
| +2 | K243712 | WasherCap™ Mini Fixation System (Model 45) | Abanza Tecnomed S.L | 2025 | — |
| +1 | K212381 | VersaTap, VersaLat, DueLock, VersaTi, MiniTi | Ortho-Design (Pty), Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2017 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (14)
See all 146 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?
- Of its descendants, K170327 (Parcus Medical, 2017) has gone furthest, with 5 descendants of its own.
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. 2012, 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 | — |
https://510kreport.com/device/K120942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120942: Parcus Twist 4 5MM Peek Suture Anchor, Parcus Twist 5.5MM Peek Suture Anchor & Parcus Triple Twist 5.5MM Peek Suture Anc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120942
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026