510(k) · Cleared
Recalled · 2003Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DePuy Orthopaedics, Inc. · HWC Screw, Fixation, Bone
Cleared on Oct 28, 1998 as substantially equivalent to K955733 (Depuy, Inc., 1996) and 4 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1994. 17 later devices descend from it. It has been recalled 4 times.
- Decided
- Oct 28, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 4
- Predicates
- 5
Its longest line of descent runs back 4 generations to K933738 (1994). 10 ancestors in all. 17 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK933738 M. Kurosaka Interference Fixation ScrewDepuy, Inc. · 1994 · Recalled
- 3 generations backK955733 Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc. · 1996
- 2 generations backK980440 Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc. · 1998
- 1 generation backK981670 Depuy Profile Round Head Interference Screw and Depuy Phantom…Depuy, Inc. · 1998
- This deviceK982662 Depuy Profile Round Head Interference Screw, Depuy Phantom…DePuy Orthopaedics, Inc. · 1998
- Descendant · cites it directly · 16 of its ownK993073 Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025…Bionx Implants, Ltd. · 1999
- Descendant · 2 generations on · 15 of its ownK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
- Descendant · 3 generations on · 13 of its ownK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
- Descendant · 4 generations on · 5 of its ownK101100 Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502…Conmed Linvatec · 2010 · Recalled
- Descendant · 4 generations on · 3 of its ownK063588 Matryx Interference Screw…Conmed Linvatec Biomaterials · 2007
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K993073Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025…Bionx Implants, Ltd. · 1999 · cites it directly16descendants
- K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Linvatec Biomaterials, Inc. · 2004 · 2 generations on15descendants
- K052080Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005 · 3 generations on13descendants
- K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec · 2010 · 4 generations on5descendants
- K063588Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5Conmed Linvatec Biomaterials · 2007 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933738 | M. Kurosaka Interference Fixation Screw | Depuy, Inc. | 1994 | 2 |
| −3 | K955733 | Hyloc Interference Screw (Cannulated)/(Non-Cannulated) | Depuy, Inc. | 1996 | — |
| −2 | K980440 | Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference Screw | Depuy, Inc. | 1998 | — |
| −1 | K981670 | Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable… | Depuy, Inc. | 1998 | — |
| 0 (this device) | K982662 | Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable… | DePuy Orthopaedics, Inc. | 1998 | — |
| +1 | 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 | — |
| +3 | K052080 | Matryx Interference Screw | Linvatec Biomaterials, Inc. | 2005 | — |
| +4 | K101100 | Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503… | Conmed Linvatec | 2010 | 2 |
| +4 | K063588 | Matryx Interference Screw… | Conmed Linvatec Biomaterials | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K955733 | Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Summary page 1…0 Smooth or threaded metallic bone fixation fastener DEVICE PRODUCT CODE: 87 HWC and MAI SUBSTANTIALLY EQUIVALENT DEVICES: eDePuy Phantom Absorbable Interference Screw (K955733, K981670) eDePuy Profile Round Head Interference Screw (K961234, K981670) sLinvatec BioScrew Absorbable Interference Screw (K9606… | 1996 |
| * | K981670 | Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference…Summary page 1…or threaded metallic bone fixation fastener DEVICE PRODUCT CODE: 87 HWC and MAI SUBSTANTIALLY EQUIVALENT DEVICES: eDePuy Phantom Absorbable Interference Screw (K955733, K981670) eDePuy Profile Round Head Interference Screw (K961234, K981670) sLinvatec BioScrew Absorbable Interference Screw (K960652, K9609… | 1998 |
| * | K961234 | Depuy Advantage Fixation Screw SystemSummary page 1…UCT CODE: 87 HWC and MAI SUBSTANTIALLY EQUIVALENT DEVICES: eDePuy Phantom Absorbable Interference Screw (K955733, K981670) eDePuy Profile Round Head Interference Screw (K961234, K981670) sLinvatec BioScrew Absorbable Interference Screw (K960652, K960940) DEVICE DESCRIPTION AND INTENDED USE: The DePuy In… | 1996 |
| * | K960652 | Bioscrew Absorbable Interference ScrewSummary page 1…hantom Absorbable Interference Screw (K955733, K981670) eDePuy Profile Round Head Interference Screw (K961234, K981670) sLinvatec BioScrew Absorbable Interference Screw (K960652, K960940) DEVICE DESCRIPTION AND INTENDED USE: The DePuy Interference Screw Systems are cannulated fully threaded cancellous bo… | 1996 |
| * | K960940 | Bioscrew Absorbable Interference ScrewSummary page 1…sorbable Interference Screw (K955733, K981670) eDePuy Profile Round Head Interference Screw (K961234, K981670) sLinvatec BioScrew Absorbable Interference Screw (K960652, K960940) DEVICE DESCRIPTION AND INTENDED USE: The DePuy Interference Screw Systems are cannulated fully threaded cancellous bone screws… | 1996 |
What descends from it? (17)
See all 171 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993073 | Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025… | 1999 | 16 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 16, 2003 | Not classified | Z-1004-03 | Other | Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20 mm may be a 7 X 25mm |
| Jun 16, 2003 | Not classified | Z-1005-03 | Other | Mislabeled -Incorrect Screw Size. The unit labeled 7x 25 mm screw may be a 8 x2 0 mm; and the unit labeled 8 x20mm may be a 7 X 25mm |
| Feb 28, 2003 | Not classified | Z-0699-03 | Other | Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 20 mm |
| Feb 28, 2003 | Not classified | Z-0698-03 | Other | Mislabeled product: Screw length incorrectly labeled may contain a 30 mm instead of 25 mm |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.4 years on median.
- 1 of the 10 ancestors has a recall of any class.
- Of its descendants, K993073 (Bionx Implants, Ltd., 1999) has gone furthest, with 16 descendants of its own.
- 3 other devices also cite its predicate K955733.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 DePuy Interference Screw Systems are intended to be used to provide interference fixation of bone-patellar tendon-bone grafts in anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL) reconstruction and of soft tissue grafts in ACL reconstruction.
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/K982662 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982662: Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982662
Report an extraction error
Are you the manufacturer?
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