510(k) · Cleared
ClearedMegafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C, 2870823C, 2870828C, 2870928C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
KARL STORZ Endoscopy-America, Inc. · HWC Screw, Fixation, Bone
Cleared on Sep 12, 2007 as substantially equivalent to K013107 (Karl Storz Endoscopy, 2002) and 5 other predicates after a 112-day review. Its family tree reaches back 9 generations to 1994. 1 later device descends from it.
- Decided
- Sep 12, 2007
- Review
- 112 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 9 generations to K933738 (1994). 43 ancestors in all, the oldest K895711 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK933738 M. Kurosaka Interference Fixation ScrewDepuy, Inc. · 1994 · Recalled
- 5 generations between
- 3 generations backK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
- 2 generations backK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
- 1 generation backK063588 Matryx Interference Screw…Conmed Linvatec Biomaterials · 2007
- This deviceK071437 Megafix-C Bioabsorbable Composite Interference Screw, Model…KARL STORZ Endoscopy-America, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK203335 MectaScrew ExtensionMedacta International S.A. · 2022
Show all 9 generations
- Root · 9 generations backK933738 M. Kurosaka Interference Fixation ScrewDepuy, Inc. · 1994 · Recalled
- 8 generations backK955733 Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc. · 1996
- 7 generations backK980440 Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc. · 1998
- 6 generations backK981670 Depuy Profile Round Head Interference Screw and Depuy Phantom…Depuy, Inc. · 1998
- 5 generations backK982662 Depuy Profile Round Head Interference Screw, Depuy Phantom…DePuy Orthopaedics, Inc. · 1998 · Recalled
- 4 generations backK993073 Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025…Bionx Implants, Ltd. · 1999
- 3 generations backK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
- 2 generations backK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
- 1 generation backK063588 Matryx Interference Screw…Conmed Linvatec Biomaterials · 2007
- This deviceK071437 Megafix-C Bioabsorbable Composite Interference Screw, Model…KARL STORZ Endoscopy-America, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K203335MectaScrew ExtensionMedacta International S.A. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K933738 | M. Kurosaka Interference Fixation Screw | Depuy, Inc. | 1994 | 2 |
| −8 | K955733 | Hyloc Interference Screw (Cannulated)/(Non-Cannulated) | Depuy, Inc. | 1996 | — |
| −7 | K980440 | Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference Screw | Depuy, Inc. | 1998 | — |
| −6 | K981670 | Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable… | Depuy, Inc. | 1998 | — |
| −5 | K982662 | Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable… | DePuy Orthopaedics, Inc. | 1998 | 4 |
| −4 | K993073 | Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020… | Bionx Implants, Ltd. | 1999 | — |
| −3 | K032894 | Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T… | Linvatec Biomaterials, Inc. | 2004 | — |
| −2 | K052080 | Matryx Interference Screw | Linvatec Biomaterials, Inc. | 2005 | — |
| −1 | K063588 | Matryx Interference Screw… | Conmed Linvatec Biomaterials | 2007 | — |
| 0 (this device) | K071437 | Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C… | KARL STORZ Endoscopy-America, Inc. | 2007 | — |
| +1 | K203335 | MectaScrew Extension | Medacta International S.A. | 2022 | — |
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 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (6)
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 |
|---|---|---|---|
| * | K013107 | Bioabsorbable Interference Screw MegafixSummary page 1…Interfeiiance Screw Classification Name: Screw, Fixation, Bone Regulation Number: 21 CFR 888.3040 Product Code: HWC Predicate Device(s): KSEA MegaFix® (K013107) Sciences for Biomaterials Ligafix® (K061262, K050407) Conmed Linvatec Biomaterials… | 2002 |
| * | K061262 | Ligafix Interference ScrewSummary page 1…gulation Number: 21 CFR 888.3040 Product Code: HWC Predicate Device(s): KSEA MegaFix® (K013107) Sciences for Biomaterials Ligafix® (K061262, K050407) Conmed Linvatec Biomaterials Matryx TM (K063588, K052080) DePuy Mitek Mil… | 2006 |
| * | K050407 | Ligafix Resorbable Interference Screw, Models 30 and 60Summary page 1…Number: 21 CFR 888.3040 Product Code: HWC Predicate Device(s): KSEA MegaFix® (K013107) Sciences for Biomaterials Ligafix® (K061262, K050407) Conmed Linvatec Biomaterials Matryx TM (K063588, K052080) DePuy Mitek Milagro (K06… | 2005 |
| * | K063588 | Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5Summary page 1…s): KSEA MegaFix® (K013107) Sciences for Biomaterials Ligafix® (K061262, K050407) Conmed Linvatec Biomaterials Matryx TM (K063588, K052080) DePuy Mitek Milagro (K060830) Device Description: The KSEA MegaFix®-C Bioabsorbable Composite… | 2007 |
| * | K052080 | Matryx Interference ScrewSummary page 1…A MegaFix® (K013107) Sciences for Biomaterials Ligafix® (K061262, K050407) Conmed Linvatec Biomaterials Matryx TM (K063588, K052080) DePuy Mitek Milagro (K060830) Device Description: The KSEA MegaFix®-C Bioabsorbable Composite Interfer… | 2005 |
| * | K060830 | Milagro Interference ScrewSummary page 1…for Biomaterials Ligafix® (K061262, K050407) Conmed Linvatec Biomaterials Matryx TM (K063588, K052080) DePuy Mitek Milagro (K060830) Device Description: The KSEA MegaFix®-C Bioabsorbable Composite Interference Screw is a one- time use… | 2006 |
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 |
|---|---|---|---|
| K203335 | MectaScrew Extension | 2022 | 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 13 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 4 of the 43 ancestors have a recall of any class.
- Of its descendants, K203335 (Medacta International S.A., 2022) has gone furthest, with 0 descendants of its own.
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 KSEA MegaFix®-C Elioabsorbable Composite Interference Screw is intended for use by qualified surgeons for tibial and femoral fixation (primary anchorage) of tendon grafts in human cruciate ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071437 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071437: Megafix-C Bioabsorbable Composite Interference Screw, Model 2870719C, 2870723C, 2870823C, 2870828C, 2870928C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071437
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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