510(k) · Cleared
ClearedMectaScrew Extension
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medacta International S.A. · HWC Screw, Fixation, Bone
Cleared on Feb 3, 2022 as substantially equivalent to K071437 (KARL STORZ Endoscopy-America, Inc., 2007) and 1 other predicate after a 448-day review. Its family tree reaches back 10 generations to 1994.
- Decided
- Feb 3, 2022
- Review
- 448 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K933738 (1994). 61 ancestors in all, the oldest K895711 (1990). No later device cites it as a predicate yet.
- Root · 10 generations backK933738 M. Kurosaka Interference Fixation ScrewDepuy, Inc. · 1994 · Recalled
- 6 generations between
- 3 generations backK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
- 2 generations backK063588 Matryx Interference Screw…Conmed Linvatec Biomaterials · 2007
- 1 generation backK071437 Megafix-C Bioabsorbable Composite Interference Screw, Model…KARL STORZ Endoscopy-America, Inc. · 2007
- This deviceK203335 MectaScrew ExtensionMedacta International S.A. · 2022
Show all 10 generations
- Root · 10 generations backK933738 M. Kurosaka Interference Fixation ScrewDepuy, Inc. · 1994 · Recalled
- 9 generations backK955733 Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc. · 1996
- 8 generations backK980440 Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc. · 1998
- 7 generations backK981670 Depuy Profile Round Head Interference Screw and Depuy Phantom…Depuy, Inc. · 1998
- 6 generations backK982662 Depuy Profile Round Head Interference Screw, Depuy Phantom…DePuy Orthopaedics, Inc. · 1998 · Recalled
- 5 generations backK993073 Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025…Bionx Implants, Ltd. · 1999
- 4 generations backK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
- 3 generations backK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
- 2 generations backK063588 Matryx Interference Screw…Conmed Linvatec Biomaterials · 2007
- 1 generation backK071437 Megafix-C Bioabsorbable Composite Interference Screw, Model…KARL STORZ Endoscopy-America, Inc. · 2007
- This deviceK203335 MectaScrew ExtensionMedacta International S.A. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K933738 | M. Kurosaka Interference Fixation Screw | Depuy, Inc. | 1994 | 2 |
| −9 | K955733 | Hyloc Interference Screw (Cannulated)/(Non-Cannulated) | Depuy, Inc. | 1996 | — |
| −8 | K980440 | Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference Screw | Depuy, Inc. | 1998 | — |
| −7 | K981670 | Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable… | Depuy, Inc. | 1998 | — |
| −6 | K982662 | Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable… | DePuy Orthopaedics, Inc. | 1998 | 4 |
| −5 | K993073 | Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020… | Bionx Implants, Ltd. | 1999 | — |
| −4 | K032894 | Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T… | Linvatec Biomaterials, Inc. | 2004 | — |
| −3 | K052080 | Matryx Interference Screw | Linvatec Biomaterials, Inc. | 2005 | — |
| −2 | K063588 | Matryx Interference Screw… | Conmed Linvatec Biomaterials | 2007 | — |
| −1 | K071437 | Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C… | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| 0 (this device) | K203335 | MectaScrew Extension | Medacta International S.A. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 4 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2019 | 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? (2)
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 |
|---|---|---|---|
| * | K071437 | Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C…Summary page 4…Predicate Device Substantial equivalence is claimed to the following primary predicate device: KSEA Megafix-C Bioabsorbable Composite Interference Screw, K071437, Karl Storz Endoscopy – America, Inc Substantial equivalence is claimed to the following secondary predicate device:… | 2007 |
| * | K190892 | MectaScrew PEEK Interference ScrewSummary page 4…rence Screw, K071437, Karl Storz Endoscopy – America, Inc Substantial equivalence is claimed to the following secondary predicate device: MectaScrew PEEK, K190892, Medacta International SA IV. Device Description The MectaScrew Extension includes implantable devices used for the tibia… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 28 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 9 of the 61 ancestors have a recall of any class.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Reconstructive treatment of ruptured anterior and posterior cruciate ligaments by means of auto- and allografts.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203335 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203335: MectaScrew Extension.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203335
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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