510(k) · Cleared
ClearedMatryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Linvatec Biomaterials · HWC Screw, Fixation, Bone
Cleared on Mar 2, 2007 as substantially equivalent to K933719 (Linvatec Corp., 1994) and 3 other predicates after a 92-day review. Its family tree reaches back 8 generations to 1994. 3 later devices descend from it.
- Decided
- Mar 2, 2007
- Review
- 92 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K933738 (1994). 31 ancestors in all, the oldest K895711 (1990). 3 later devices descend from it, 2 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 deviceK063588 Matryx Interference Screw…Conmed Linvatec Biomaterials · 2007
- Descendant · cites it directly · 1 of its ownK071437 Megafix-C Bioabsorbable Composite Interference Screw, Model…KARL STORZ Endoscopy-America, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK203335 MectaScrew ExtensionMedacta International S.A. · 2022
- Descendant · cites it directly · 0 of its ownK092998 Conmed Linvatec Intercept ImplantLinvatec Corp. · 2009
Most influential descendants
Showing 3 of 3 · See all- K071437Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C…KARL STORZ Endoscopy-America, Inc. · 2007 · cites it directly1descendant
- K203335MectaScrew ExtensionMedacta International S.A. · 2022 · 2 generations on0descendants
- K092998Conmed Linvatec Intercept ImplantLinvatec Corp. · 2009 · cites it directly0descendants
View 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) | K063588 | Matryx Interference Screw… | Conmed Linvatec Biomaterials | 2007 | — |
| +1 | K071437 | Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C… | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| +2 | K203335 | MectaScrew Extension | Medacta International S.A. | 2022 | — |
| +1 | K092998 | Conmed Linvatec Intercept Implant | Linvatec Corp. | 2009 | — |
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 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K933719 | Bioscrew Absorbable Interference ScrewSummary page 1…erence Screw C. Classification Name: Bone Fixation Screw D. Device Product Code: MAI and HWC Predicate Device: 1. ConMed Linvatec BioScrew (K933719, K952831, K973758), ConMed Linvatec Biomaterials MatryxTM Interference Screw (K052080) Intended Use: The MatryxTM Interferen… | 1994 |
| * | K952831 | Bioscrew Absorbable Interference ScrewSummary page 1…rew C. Classification Name: Bone Fixation Screw D. Device Product Code: MAI and HWC Predicate Device: 1. ConMed Linvatec BioScrew (K933719, K952831, K973758), ConMed Linvatec Biomaterials MatryxTM Interference Screw (K052080) Intended Use: The MatryxTM Interference Screw… | 1995 |
| * | K973758 | Bioscrew Absorbable Interference SrewSummary page 1…Classification Name: Bone Fixation Screw D. Device Product Code: MAI and HWC Predicate Device: 1. ConMed Linvatec BioScrew (K933719, K952831, K973758), ConMed Linvatec Biomaterials MatryxTM Interference Screw (K052080) Intended Use: The MatryxTM Interference Screw is intend… | 1998 |
| * | K052080 | Matryx Interference ScrewSummary page 1…uct Code: MAI and HWC Predicate Device: 1. ConMed Linvatec BioScrew (K933719, K952831, K973758), ConMed Linvatec Biomaterials MatryxTM Interference Screw (K052080) Intended Use: The MatryxTM Interference Screw is intended for use in interference fixation of bone - patellar tendon - bone an… | 2005 |
What descends from it? (3)
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 13 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 31 ancestors have a recall of any class.
- Of its descendants, K071437 (KARL STORZ Endoscopy-America, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K933719.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 MatryxTM Interference Screw is intended for use in interference fixation of bone - patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions. The MatryxTM Interference Screw is not intended for use in and is contraindicated for 1) Insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitations and/or previous infections, which could retard healing, 3) Foreign body…
Read the full statement (133 words)
The MatryxTM Interference Screw is intended for use in interference fixation of bone - patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.
The MatryxTM Interference Screw is not intended for use in and is contraindicated for 1) Insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitations and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant material. Where the material is suspected a test should be made prior to implantation to rule out sensitivity, 4) Patients with active sepsis or infection, 5) Conditions which tend to limit the patient's ability or willingness to restrict activities or follow directions during the healing and rehabilitation period, 6) ACL repairs which would not be appropriate for fixation with metallic screws
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063588 · printed Nov 5, 2026
Cite this page
510(k) Report. “K063588: Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063588
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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