510(k) · Cleared
ClearedParcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Parcus Medical, LLC · HWC Screw, Fixation, Bone
Cleared on Mar 6, 2009 as substantially equivalent to K062466 (Arthrex, Inc., 2006) and 2 other predicates after an 88-day review. Its family tree reaches back 4 generations to 1993. 7 later devices descend from it.
- Decided
- Mar 6, 2009
- Review
- 88 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K915424 (1993). 14 ancestors in all, the oldest K895711 (1990). 7 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK915424 Arthrex Cannulated Interference ScrewArthrex, Inc. · 1993
- 3 generations backK980841 Rci Fixation ScrewsSmith & Nephew, Inc. · 1998
- 2 generations backK992396 Biorci ScrewSmith & Nephew Endoscopy, Inc. · 2000
- 1 generation backK032224 Biorci ScrewSmith & Nephew, Inc. · 2003
- This deviceK083619 Parcus Tintanium Interference Screw, Models: 10001-10012…Parcus Medical, LLC · 2009
- Descendant · cites it directly · 4 of its ownK091093 Parcus Ppek CF Interference ScrewParcus Medical, LLC · 2009
- Descendant · 2 generations on · 1 of its ownK170877 Parcus SLiK Fix ScrewParcus Medical · 2017
- Descendant · 2 generations on · 1 of its ownK111471 Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX…Medshape Solutions, Inc. · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK203029 Auxilock Titanium Interference ScrewAuxein Medical Private Limited · 2021
- Descendant · cites it directly · 0 of its ownK202662 Parcus Titanium Interference ScrewsParcus Medical, LLC · 2021
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K091093Parcus Ppek CF Interference ScrewParcus Medical, LLC · 2009 · cites it directly4descendants
- K170877Parcus SLiK Fix ScrewParcus Medical · 2017 · 2 generations on1descendant
- K111471Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size)Medshape Solutions, Inc. · 2011 · 2 generations on1descendant
- K203029Auxilock Titanium Interference ScrewAuxein Medical Private Limited · 2021 · cites it directly0descendants
- K202662Parcus Titanium Interference ScrewsParcus Medical, LLC · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915424 | Arthrex Cannulated Interference Screw | Arthrex, Inc. | 1993 | — |
| −3 | K980841 | Rci Fixation Screws | Smith & Nephew, Inc. | 1998 | — |
| −2 | K992396 | Biorci Screw | Smith & Nephew Endoscopy, Inc. | 2000 | — |
| −1 | K032224 | Biorci Screw | Smith & Nephew, Inc. | 2003 | — |
| 0 (this device) | K083619 | Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016… | Parcus Medical, LLC | 2009 | — |
| +1 | K091093 | Parcus Ppek CF Interference Screw | Parcus Medical, LLC | 2009 | — |
| +2 | K170877 | Parcus SLiK Fix Screw | Parcus Medical | 2017 | — |
| +2 | K111471 | Exoshape (TM) Interference Fixation Device Model 1100-00-XXXX (Varies by Size) | Medshape Solutions, Inc. | 2011 | 1 |
| +1 | K203029 | Auxilock Titanium Interference Screw | Auxein Medical Private Limited | 2021 | — |
| +1 | K202662 | Parcus Titanium Interference Screws | Parcus Medical, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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 HWC? 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 HWC device
- #1 K203011 Monster Screw Systemscore 22.2 · 14 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K062466 | Arthrex Interference ScrewSummary page 1…Fastener, Fixation, Non-Degradable, Soft Tissue 21 CFR 888.3040 - Product Code HWC and MBI Predicate Devices: Arthrex Interference Screw (K062466) * Smith & Nephew BioRCI Screw (K032224) . Smith & Nephew Titanium Interference Screws (K040331) Device Descripti'on: The Pa… | 2006 |
| * | K032224 | Biorci ScrewSummary page 1…t Tissue 21 CFR 888.3040 - Product Code HWC and MBI Predicate Devices: Arthrex Interference Screw (K062466) * Smith & Nephew BioRCI Screw (K032224) . Smith & Nephew Titanium Interference Screws (K040331) Device Descripti'on: The Parcus-Titanium Interference Screw is a cann… | 2003 |
| * | K040331 | Smith and Nephew Titanium Interference ScrewsSummary page 1…Code HWC and MBI Predicate Devices: Arthrex Interference Screw (K062466) * Smith & Nephew BioRCI Screw (K032224) . Smith & Nephew Titanium Interference Screws (K040331) Device Descripti'on: The Parcus-Titanium Interference Screw is a cannulated, threaded, tapered fastener for use in interference… | 2004 |
What descends from it? (7)
3 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 16 years and passes through 4 companies; a new generation was cleared every 5.3 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K091093 (Parcus Medical, LLC, 2009) has gone furthest, with 4 descendants of its own.
- 12 other devices also cite its predicate K062466.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · HWC
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HWC
111in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HWC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HWC
2,893in 2025
MAUDE reports naming product code HWC, 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 | 35 | 77 | 25 | 669 |
| 2008 | 33 | 76 | 33 | 660 |
| 2009 | 27 | 113 | 29 | 651 |
| 2010 | 23 | 110 | 7 | 765 |
| 2011 | 35 | 88 | 12 | 1,104 |
| 2012 | 20 | 99 | 30 | 3,339 |
| 2013 | 25 | 90 | 14 | 3,850 |
| 2014 | 31 | 88 | 2 | 2,549 |
| 2015 | 41 | 85 | 5 | 2,711 |
| 2016 | 26 | 131 | 4 | 2,285 |
| 2017 | 40 | 127 | 4 | 2,561 |
| 2018 | 20 | 106 | 1 | 3,662 |
| 2019 | 30 | 108 | 5 | 5,463 |
| 2020 | 28 | 75 | 4 | 4,820 |
| 2021 | 26 | 84 | 2 | 4,446 |
| 2022 | 26 | 167 | 13 | 3,934 |
| 2023 | 24 | 104 | 0 | 3,718 |
| 2024 | 17 | 90 | 0 | 3,575 |
| 2025 | 15 | 111 | 1 | 2,893 |
| 2026 | 21 | 125 | 2 | — |
What is it indicated for?
The Parcus Titanium Interference Screw is indicated for use in the fixation of ligaments and tendons in patients requiring ligament or tendon repair.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083619 · printed Nov 5, 2026
Cite this page
510(k) Report. “K083619: Parcus Tintanium Interference Screw, Models: 10001-10012, 10014-10016, 10018-10020.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K083619
Report an extraction error
Are you the manufacturer?
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