510(k) · Cleared
ClearedProCinch Adjustable Loop Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stryker Endoscopy · HTY Pin, Fixation, Smooth
Cleared on Apr 17, 2015 as substantially equivalent to K112990 (Arthrex, Inc., 2011) after a 58-day review. Its family tree reaches back 8 generations to 1990. 1 later device descends from it.
- Decided
- Apr 17, 2015
- Review
- 58 days
- Class
- Class II
- Product code
- HTY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K904436 (1990). 28 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK904436 Quickanchor (TM)Mitek Surgical Products, Inc. · 1990
- 7 generations backK962397 Statak Soft Tissue Attachment DeviceZimmer, Inc. · 1996
- 6 generations backK973015 Multitak SS Suture SystemBonutti Research · 1997
- 5 generations backK990156 Multitak SS ButtonsBonutti Research · 1999
- 4 generations backK031666 Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DSArthrex, Inc. · 2003 · Recalled
- 3 generations backK062747 Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MMArthrex, Inc. · 2006
- 2 generations backK100652 Acl TightropeArthrex, Inc. · 2010
- 1 generation backK112990 Acl Tightrope,Acl Tightrope Duuble BundleArthrex, Inc. · 2011
- This deviceK150416 ProCinch Adjustable Loop DeviceStryker Endoscopy · 2015
- Descendant · cites it directly · 0 of its ownK210078 Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy · 2021
Most influential descendants
Showing 1 of 1 · See all- K210078Stryker ProCinch Adjustable Loop DeviceStryker Endoscopy · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K904436 | Quickanchor (TM) | Mitek Surgical Products, Inc. | 1990 | — |
| −7 | K962397 | Statak Soft Tissue Attachment Device | Zimmer, Inc. | 1996 | — |
| −6 | K973015 | Multitak SS Suture System | Bonutti Research | 1997 | — |
| −5 | K990156 | Multitak SS Buttons | Bonutti Research | 1999 | — |
| −4 | K031666 | Arthrex Fiberwire Button Repair Kit, Model AR-8920DS/AR-8921DS | Arthrex, Inc. | 2003 | 1 |
| −3 | K062747 | Arthrex Retrobutton, 15MM, 60MM, Retrobutton, Long, 15MM, 60MM | Arthrex, Inc. | 2006 | — |
| −2 | K100652 | Acl Tightrope | Arthrex, Inc. | 2010 | — |
| −1 | K112990 | Acl Tightrope,Acl Tightrope Duuble Bundle | Arthrex, Inc. | 2011 | — |
| 0 (this device) | K150416 | ProCinch Adjustable Loop Device | Stryker Endoscopy | 2015 | — |
| +1 | K210078 | Stryker ProCinch Adjustable Loop Device | Stryker Endoscopy | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 HTY? 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 HTY device
- #1 K231272 OSSIOfiber® Pin Product Family, OSSIOfiber®…score 19.3 · 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? (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 |
|---|---|---|---|
| * | K112990 | Acl Tightrope,Acl Tightrope Duuble BundleSummary page 4…or threaded metallic bone fixation fastener (21 CFR 888.3040 Regulatory Class: II Product Code: HTY III. PREDICATE DEVICE Arthrex ACL TightRope, K112990 This predicate has not been reported by the manufacturer as being subject to a design-related recall. No reference devices were… | 2011 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210078 | Stryker ProCinch Adjustable Loop Device | 2021 | 0 |
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 25 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 4 of the 28 ancestors have a recall of any class.
- Of its descendants, K210078 (Stryker Endoscopy, 2021) has gone furthest, with 0 descendants of its own.
- 9 other devices also cite its predicate K112990.
How does its category compare?
All HTY devicesHTY Pin, Fixation, Smooth: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · HTY
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HTY
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HTY
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HTY
39in 2025
MAUDE reports naming product code HTY, 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 | 6 | 112 | 0 | 46 |
| 2008 | 6 | 86 | 0 | 38 |
| 2009 | 2 | — | 1 | 36 |
| 2010 | 9 | 180 | 1 | 33 |
| 2011 | 6 | 82 | 0 | 164 |
| 2012 | 4 | 76 | 0 | 129 |
| 2013 | 4 | 128 | 0 | 187 |
| 2014 | 8 | 73 | 0 | 149 |
| 2015 | 8 | 101 | 0 | 121 |
| 2016 | 6 | 114 | 2 | 128 |
| 2017 | 5 | 127 | 0 | 82 |
| 2018 | 4 | 162 | 0 | 138 |
| 2019 | 4 | 93 | 1 | 222 |
| 2020 | 5 | 108 | 0 | 210 |
| 2021 | 5 | 137 | 0 | 148 |
| 2022 | 4 | 121 | 2 | 96 |
| 2023 | 5 | 146 | 0 | 153 |
| 2024 | 1 | — | 0 | 297 |
| 2025 | 5 | 90 | 0 | 39 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Stryker ProCinch Adjustable Loop Fixation Device is intended for the fixation of bone-to-bone or soft tissue-to-bone as fixation posts, a distribution bridge, or for distributing suture tension during Anterior Cruciate Ligament (ACL) and Posterior Cruciate Ligament (PCL) Repair and Reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150416 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150416: ProCinch Adjustable Loop Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150416
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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