510(k) · Cleared
ClearedOsteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linvatec Biomaterials, Inc. · HWC Screw, Fixation, Bone
Cleared on May 7, 2004 as substantially equivalent to K993073 (Bionx Implants, Ltd., 1999) and 6 other predicates after a 233-day review. Its family tree reaches back 6 generations to 1994. 15 later devices descend from it.
- Decided
- May 7, 2004
- Review
- 233 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 6 generations to K933738 (1994). 29 ancestors in all, the oldest K895711 (1990). 15 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK933738 M. Kurosaka Interference Fixation ScrewDepuy, Inc. · 1994 · Recalled
- 5 generations backK955733 Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc. · 1996
- 4 generations backK980440 Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc. · 1998
- 3 generations backK981670 Depuy Profile Round Head Interference Screw and Depuy Phantom…Depuy, Inc. · 1998
- 2 generations backK982662 Depuy Profile Round Head Interference Screw, Depuy Phantom…DePuy Orthopaedics, Inc. · 1998 · Recalled
- 1 generation backK993073 Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025…Bionx Implants, Ltd. · 1999
- This deviceK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
- Descendant · cites it directly · 13 of its ownK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
- Descendant · 2 generations on · 5 of its ownK101100 Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502…Conmed Linvatec · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK063588 Matryx Interference Screw…Conmed Linvatec Biomaterials · 2007
- Descendant · 3 generations on · 2 of its ownK170501 CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation · 2017
- Descendant · cites it directly · 2 of its ownK102410 Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec · 2010
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K052080Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005 · cites it directly13descendants
- K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec · 2010 · 2 generations on5descendants
- K063588Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5Conmed Linvatec Biomaterials · 2007 · 2 generations on3descendants
- K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation · 2017 · 3 generations on2descendants
- K102410Matryx Interference Screw (5.0-6.5MM)Conmed Linvatec · 2010 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K933738 | M. Kurosaka Interference Fixation Screw | Depuy, Inc. | 1994 | 2 |
| −5 | K955733 | Hyloc Interference Screw (Cannulated)/(Non-Cannulated) | Depuy, Inc. | 1996 | — |
| −4 | K980440 | Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference Screw | Depuy, Inc. | 1998 | — |
| −3 | K981670 | Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable… | Depuy, Inc. | 1998 | — |
| −2 | K982662 | Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable… | DePuy Orthopaedics, Inc. | 1998 | 4 |
| −1 | K993073 | Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020… | Bionx Implants, Ltd. | 1999 | — |
| 0 (this device) | K032894 | Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T… | Linvatec Biomaterials, Inc. | 2004 | — |
| +1 | K052080 | Matryx Interference Screw | Linvatec Biomaterials, Inc. | 2005 | — |
| +2 | K101100 | Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503… | Conmed Linvatec | 2010 | 2 |
| +2 | K063588 | Matryx Interference Screw… | Conmed Linvatec Biomaterials | 2007 | — |
| +3 | K170501 | CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver | Conmed Corporation | 2017 | — |
| +1 | K102410 | Matryx Interference Screw (5.0-6.5MM) | Conmed Linvatec | 2010 | — |
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 |
|---|---|---|
| 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? (7)
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 |
|---|---|---|---|
| * | K993073 | Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025…Summary page 1…e: Bone Fixation Screw D. Device Product Code: MAI and HWC Puredicate Device: 1. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) K993073 2. Mitek Products Mitek Biocryl Interference Screws (KO12572) 3. Linvatec Inc BioScrew (K933719, K952831, K973758) 4. Biocomposit… | 1999 |
| * | K012572 | Soft Tissue Screw and Washer | 2001 |
| * | K933719 | Bioscrew Absorbable Interference ScrewSummary page 1…Device: 1. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) K993073 2. Mitek Products Mitek Biocryl Interference Screws (KO12572) 3. Linvatec Inc BioScrew (K933719, K952831, K973758) 4. Biocomposites Ltd Biolok (K993630, K002070) Intended Use: The Osteo ACL ScrewTM is intended for use in in… | 1994 |
| * | K952831 | Bioscrew Absorbable Interference ScrewSummary page 1…1. Linvatec Biomaterials Ltd (the previous Bionx Implants, Inc.) K993073 2. Mitek Products Mitek Biocryl Interference Screws (KO12572) 3. Linvatec Inc BioScrew (K933719, K952831, K973758) 4. Biocomposites Ltd Biolok (K993630, K002070) Intended Use: The Osteo ACL ScrewTM is intended for use in interferenc… | 1995 |
| * | K973758 | Bioscrew Absorbable Interference SrewSummary page 1…ec Biomaterials Ltd (the previous Bionx Implants, Inc.) K993073 2. Mitek Products Mitek Biocryl Interference Screws (KO12572) 3. Linvatec Inc BioScrew (K933719, K952831, K973758) 4. Biocomposites Ltd Biolok (K993630, K002070) Intended Use: The Osteo ACL ScrewTM is intended for use in interference fixatio… | 1998 |
| * | K993630 | Biolok ScrewSummary page 1…x Implants, Inc.) K993073 2. Mitek Products Mitek Biocryl Interference Screws (KO12572) 3. Linvatec Inc BioScrew (K933719, K952831, K973758) 4. Biocomposites Ltd Biolok (K993630, K002070) Intended Use: The Osteo ACL ScrewTM is intended for use in interference fixation of bone-patellar tendon - bone and s… | 2000 |
| * | K002070 | Biolok ScrewSummary page 1…s, Inc.) K993073 2. Mitek Products Mitek Biocryl Interference Screws (KO12572) 3. Linvatec Inc BioScrew (K933719, K952831, K973758) 4. Biocomposites Ltd Biolok (K993630, K002070) Intended Use: The Osteo ACL ScrewTM is intended for use in interference fixation of bone-patellar tendon - bone and soft tissu… | 2000 |
What descends from it? (15)
See all 153 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 10 years and passes through 4 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K052080 (Linvatec Biomaterials, Inc., 2005) has gone furthest, with 13 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.
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 Osteo ACL Screw TM is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions. The Osteo ACL ScrewTM is not intended for use in and is contraindicated for 1) insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitation and/or previous infections, which could retard healing, 3) Foreign body sensitivity to the implant…
Read the full statement (132 words)
The Osteo ACL Screw TM is intended for use in interference fixation of bone-patellar tendon - bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.
The Osteo ACL ScrewTM is not intended for use in and is contraindicated for 1) insufficient quality and quantity of bone for attachment of graft, 2) Blood supply limitation 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/K032894 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032894: Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T, 239025T, 239030T, 231020T, 231025T,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032894
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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