510(k) · Cleared
ClearedMatryx Interference Screw (5.0-6.5MM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Linvatec · HWC Screw, Fixation, Bone
Cleared on Dec 21, 2010 as substantially equivalent to K032894 (Linvatec Biomaterials, Inc., 2004) and 3 other predicates after a 119-day review. Its family tree reaches back 8 generations to 1994. 2 later devices descend from it.
- Decided
- Dec 21, 2010
- Review
- 119 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K933738 (1994). 38 ancestors in all, the oldest K895711 (1990). 2 later devices descend from it, 1 citing it directly.
- Root · 8 generations backK933738 M. Kurosaka Interference Fixation ScrewDepuy, Inc. · 1994 · Recalled
- 7 generations backK955733 Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc. · 1996
- 6 generations backK980440 Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc. · 1998
- 5 generations backK981670 Depuy Profile Round Head Interference Screw and Depuy Phantom…Depuy, Inc. · 1998
- 4 generations backK982662 Depuy Profile Round Head Interference Screw, Depuy Phantom…DePuy Orthopaedics, Inc. · 1998 · Recalled
- 3 generations backK993073 Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025…Bionx Implants, Ltd. · 1999
- 2 generations backK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
- 1 generation backK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
- This deviceK102410 Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec · 2010
- Descendant · cites it directly · 1 of its ownK120589 Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company · 2012
- Descendant · 2 generations on · 0 of its ownK122869 Milagro Interference ScrewsDepuy Mitek, A Johnson & Johnson Company · 2012
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 |
|---|---|---|---|---|---|
| −8 | K933738 | M. Kurosaka Interference Fixation Screw | Depuy, Inc. | 1994 | 2 |
| −7 | K955733 | Hyloc Interference Screw (Cannulated)/(Non-Cannulated) | Depuy, Inc. | 1996 | — |
| −6 | K980440 | Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference Screw | Depuy, Inc. | 1998 | — |
| −5 | K981670 | Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable… | Depuy, Inc. | 1998 | — |
| −4 | K982662 | Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable… | DePuy Orthopaedics, Inc. | 1998 | 4 |
| −3 | K993073 | Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020… | Bionx Implants, Ltd. | 1999 | — |
| −2 | K032894 | Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T… | Linvatec Biomaterials, Inc. | 2004 | — |
| −1 | K052080 | Matryx Interference Screw | Linvatec Biomaterials, Inc. | 2005 | — |
| 0 (this device) | K102410 | Matryx Interference Screw (5.0-6.5MM) | Conmed Linvatec | 2010 | — |
| +1 | K120589 | Milagro Interference Screws | Depuy Mitek, A Johnson & Johnson Company | 2012 | — |
| +2 | K122869 | Milagro Interference Screws | Depuy Mitek, A Johnson & Johnson Company | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 3 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (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 |
|---|---|---|---|
| * | K032894 | Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Summary page 1…evices Device Name: Osteo AOIL Screw Company Name: Linvatec Biomnaterials Ltd. 510O(k) #: K032894 Device Name: Matryx Interference Screw Company Name: Linvatec Biomnaterials L… | 2004 |
| * | K052080 | Matryx Interference ScrewSummary page 1…Device Name: Matryx Interference Screw Company Name: Linvatec Biomnaterials Ltd. 510O(k) #: K052080 Device Name: MILAGRO Interference Screw Company Name: Depuy Mitek 510O(k)… | 2005 |
| * | K060830 | Milagro Interference ScrewSummary page 1…K052080 Device Name: MILAGRO Interference Screw Company Name: Depuy Mitek 510O(k) #: K060830 - ~hIZWD~mZ/2) riL [I NV AT E C 11311… | 2006 |
| * | K071091 | Modification to Bilok ScrewSummary page 2…464 * vvw.inats~m Device Name: Rilok Screw Company Name: Biocomposites Ltd 510O(k) #: K071091 E. Device Description The Genesys Matryx is a threaded, cannulated, bioabsorbable interference screw composed of ultra-high st… | 2007 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120589 | Milagro Interference Screws | 2012 | 1 |
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 5 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 38 ancestors have a recall of any class.
- Of its descendants, K120589 (Depuy Mitek, A Johnson & Johnson Company, 2012) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K032894.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Genesys Matryxtm is for attaching soft tissue to bone in orthopedic surgical procedures. Genesys Matryx TM is intended to be used for interference fixation of soft tissue (including ligaments or tendons) to bone, where the implant sizes offered are patient appropriate. The implant operates in conjunction with appropriate postoperative immobilization, throughout the healing period, to attach soft tissue to bone.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102410 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102410: Matryx Interference Screw (5.0-6.5MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102410
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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