510(k) · Cleared
ClearedEZStart Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Conmed Corporation · HWC Screw, Fixation, Bone
Cleared on Jan 22, 2019 as substantially equivalent to K933352 (Linvatec Corp., 1994) after a 90-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Jan 22, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933352 (1994). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK933352 Concept Cannulated Intereference ScrewLinvatec Corp. · 1994
- This deviceK182955 EZStart Interference ScrewConmed Corporation · 2019
- Descendant · cites it directly · 0 of its ownK230595 OsteoCentric ACL Fixation SystemOsteoCentric Technologies · 2023
- Descendant · cites it directly · 0 of its ownK202569 Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC · 2020
- Descendant · cites it directly · 0 of its ownK193491 restor3d Metallic Interference ScrewRestor3D · 2020
Most influential descendants
Showing 3 of 3 · See all- K230595OsteoCentric ACL Fixation SystemOsteoCentric Technologies · 2023 · cites it directly0descendants
- K202569Responsive Arthroscopy Interference Screw SystemResponsive Arthroscopy, LLC · 2020 · cites it directly0descendants
- K193491restor3d Metallic Interference ScrewRestor3D · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933352 | Concept Cannulated Intereference Screw | Linvatec Corp. | 1994 | — |
| 0 (this device) | K182955 | EZStart Interference Screw | Conmed Corporation | 2019 | — |
| +1 | K230595 | OsteoCentric ACL Fixation System | OsteoCentric Technologies | 2023 | — |
| +1 | K202569 | Responsive Arthroscopy Interference Screw System | Responsive Arthroscopy, LLC | 2020 | — |
| +1 | K193491 | restor3d Metallic Interference Screw | Restor3D | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K933352 | Concept Cannulated Intereference ScrewSummary page 4…E Device Name: Concept Cannulated Interference Screw Company Name: Linvatec Corporation 510(k) #: K933352 IV. REFERENCE DEVICE Device Name: Guardsman® Interference Screws Company Name:… | 1994 |
| † | K960962 | Interference Screw | 1996 |
What descends from it? (3)
3 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?
- Its one ancestor has no recall.
- Of its descendants, K230595 (OsteoCentric Technologies, 2023) 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. 2019, 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?
EZ Start™ Interference Screws are used to provide bone fixation in orthopedic procedures, including bone-tendon-bone graft fixation in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction of the knee.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182955: EZStart Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182955
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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