510(k) · Cleared
ClearedSmart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bionx Implants, Ltd. · MAI Fastener, Fixation, Biodegradable, Soft Tissue
Cleared on Dec 6, 1999 as substantially equivalent to K955733 (Depuy, Inc., 1996) and 12 other predicates after an 83-day review. Its family tree reaches back 5 generations to 1994. 16 later devices descend from it.
- Decided
- Dec 6, 1999
- Review
- 83 days
- Class
- Class II
- Product code
- MAI
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 5 generations to K933738 (1994). 21 ancestors in all, the oldest K895711 (1990). 16 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK933738 M. Kurosaka Interference Fixation ScrewDepuy, Inc. · 1994 · Recalled
- 4 generations backK955733 Hyloc Interference Screw (Cannulated)/(Non-Cannulated)Depuy, Inc. · 1996
- 3 generations backK980440 Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference ScrewDepuy, Inc. · 1998
- 2 generations backK981670 Depuy Profile Round Head Interference Screw and Depuy Phantom…Depuy, Inc. · 1998
- 1 generation backK982662 Depuy Profile Round Head Interference Screw, Depuy Phantom…DePuy Orthopaedics, Inc. · 1998 · Recalled
- This deviceK993073 Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025…Bionx Implants, Ltd. · 1999
- Descendant · cites it directly · 15 of its ownK032894 Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T…Linvatec Biomaterials, Inc. · 2004
- Descendant · 2 generations on · 13 of its ownK052080 Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005
- Descendant · 3 generations on · 5 of its ownK101100 Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502…Conmed Linvatec · 2010 · Recalled
- Descendant · 3 generations on · 3 of its ownK063588 Matryx Interference Screw…Conmed Linvatec Biomaterials · 2007
- Descendant · 4 generations on · 2 of its ownK170501 CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation · 2017
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K032894Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T…Linvatec Biomaterials, Inc. · 2004 · cites it directly15descendants
- K052080Matryx Interference ScrewLinvatec Biomaterials, Inc. · 2005 · 2 generations on13descendants
- K101100Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec · 2010 · 3 generations on5descendants
- K063588Matryx Interference Screw, 239038T5,231025T5,231033T5,231038T5,231125T5,231133T5,231138T5Conmed Linvatec Biomaterials · 2007 · 3 generations on3descendants
- K170501CrossFT Knotless Biocomposite Suture Anchor with Disposable DriverConmed Corporation · 2017 · 4 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933738 | M. Kurosaka Interference Fixation Screw | Depuy, Inc. | 1994 | 2 |
| −4 | K955733 | Hyloc Interference Screw (Cannulated)/(Non-Cannulated) | Depuy, Inc. | 1996 | — |
| −3 | K980440 | Depuy Orthotech Phantom Sof-Thread Soft Tissue Interference Screw | Depuy, Inc. | 1998 | — |
| −2 | K981670 | Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable… | Depuy, Inc. | 1998 | — |
| −1 | K982662 | Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable… | DePuy Orthopaedics, Inc. | 1998 | 4 |
| 0 (this device) | K993073 | Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020… | Bionx Implants, Ltd. | 1999 | — |
| +1 | K032894 | Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T… | Linvatec Biomaterials, Inc. | 2004 | — |
| +2 | K052080 | Matryx Interference Screw | Linvatec Biomaterials, Inc. | 2005 | — |
| +3 | K101100 | Crossft OC Suture Anchor Mode CFC-4502, CFC-5502, CFC-6502, CFC-4503… | Conmed Linvatec | 2010 | 2 |
| +3 | K063588 | Matryx Interference Screw… | Conmed Linvatec Biomaterials | 2007 | — |
| +4 | K170501 | CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver | Conmed Corporation | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 5 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MAI? 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 MAI device
- #1 K203495 Arthrex SwiveLock Anchorscore 35.2 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (13)
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…cation Name: Biodegradable fixation fastener, bone and soft tissue D. Device Product Code: HWC and MAI Predicate Devices: DePuy, Inc. Phantom PLLA Interference Screw (K955733) Resorbable Interference Screw (K981670) Phantom Resorbable Interference Screw (K982662) Linvatec Corporation BioScrew Fixation… | 1996 |
| * | K981670 | Depuy Profile Round Head Interference Screw and Depuy Phantom Resorbable Interference…Summary page 1…ener, bone and soft tissue D. Device Product Code: HWC and MAI Predicate Devices: DePuy, Inc. Phantom PLLA Interference Screw (K955733) Resorbable Interference Screw (K981670) Phantom Resorbable Interference Screw (K982662) Linvatec Corporation BioScrew Fixation System (K933719, K952831, K973758) Instr… | 1998 |
| * | K982662 | Depuy Profile Round Head Interference Screw, Depuy Phantom Resorbable Interference ScrewSummary page 1…de: HWC and MAI Predicate Devices: DePuy, Inc. Phantom PLLA Interference Screw (K955733) Resorbable Interference Screw (K981670) Phantom Resorbable Interference Screw (K982662) Linvatec Corporation BioScrew Fixation System (K933719, K952831, K973758) Instrument Makar, Biologically Quiet Interference Scr… | 1998 |
| * | K933719 | Bioscrew Absorbable Interference ScrewSummary page 1…PLLA Interference Screw (K955733) Resorbable Interference Screw (K981670) Phantom Resorbable Interference Screw (K982662) Linvatec Corporation BioScrew Fixation System (K933719, K952831, K973758) Instrument Makar, Biologically Quiet Interference Screw (K943249) Biomet, Inc. Arthrotek Interference Screw (… | 1994 |
| * | K952831 | Bioscrew Absorbable Interference ScrewSummary page 1…rference Screw (K955733) Resorbable Interference Screw (K981670) Phantom Resorbable Interference Screw (K982662) Linvatec Corporation BioScrew Fixation System (K933719, K952831, K973758) Instrument Makar, Biologically Quiet Interference Screw (K943249) Biomet, Inc. Arthrotek Interference Screw (K982496)… | 1995 |
| * | K973758 | Bioscrew Absorbable Interference SrewSummary page 1…Screw (K955733) Resorbable Interference Screw (K981670) Phantom Resorbable Interference Screw (K982662) Linvatec Corporation BioScrew Fixation System (K933719, K952831, K973758) Instrument Makar, Biologically Quiet Interference Screw (K943249) Biomet, Inc. Arthrotek Interference Screw (K982496) === Page… | 1998 |
| * | K943249 | Bioabsorbable Interference ScrewSummary page 1…sorbable Interference Screw (K982662) Linvatec Corporation BioScrew Fixation System (K933719, K952831, K973758) Instrument Makar, Biologically Quiet Interference Screw (K943249) Biomet, Inc. Arthrotek Interference Screw (K982496) O S5 Arthrex, Inc. The Arthrex Bio-Interference Screw (K97… | 1995 |
| * | K982497 | Arthrotek Interference Screw Our OCR of the scanned summary read K982496, FDA’s number for Quadrature Lower Extremity Coil, Model # 473SI-42D (Medical Advances, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Biomet, Inc. Arthrotek Interference Screw”. | 1998 |
| * | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MMSummary page 2…logically Quiet Interference Screw (K943249) Biomet, Inc. Arthrotek Interference Screw (K982496) O S5 Arthrex, Inc. The Arthrex Bio-Interference Screw (K971358) Tornier S.A Phusis Absorbable Interference Screw (K970829) Acufex Microsurgical,Inc Acufex Endofix Absorbable Interference Sc… | 1997 |
| * | K970829 | Phusis Absorbable Interference ScrewSummary page 2…rthrotek Interference Screw (K982496) O S5 Arthrex, Inc. The Arthrex Bio-Interference Screw (K971358) Tornier S.A Phusis Absorbable Interference Screw (K970829) Acufex Microsurgical,Inc Acufex Endofix Absorbable Interference Screw (K954246) Smith and Nephew, Inc. Bioabsorbable Interfer… | 1998 |
| * | K954246 | Acufex Endofix Absorbable Interference ScrewSummary page 2…rex Bio-Interference Screw (K971358) Tornier S.A Phusis Absorbable Interference Screw (K970829) Acufex Microsurgical,Inc Acufex Endofix Absorbable Interference Screw (K954246) Smith and Nephew, Inc. Bioabsorbable Interference Screw (K984320) Sulzer Orthopedics, Inc. Sysorb Interference Screw (983592)… | 1996 |
| * | K984320 | Bioabsorbable Interference ScrewsSummary page 2…Interference Screw (K970829) Acufex Microsurgical,Inc Acufex Endofix Absorbable Interference Screw (K954246) Smith and Nephew, Inc. Bioabsorbable Interference Screw (K984320) Sulzer Orthopedics, Inc. Sysorb Interference Screw (983592) Intended Use: The SmartScrew ACL™ is intended for use in interfere… | 1999 |
| * | K983592 | Sulzer Orthopedics Sysorb Interference ScrewsSummary page 2…ex Endofix Absorbable Interference Screw (K954246) Smith and Nephew, Inc. Bioabsorbable Interference Screw (K984320) Sulzer Orthopedics, Inc. Sysorb Interference Screw (983592) Intended Use: The SmartScrew ACL™ is intended for use in interference fixation of bone-patellar tendon — bone and soft tissue… | 1999 |
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032894 | Osteo Acl Screw Model;237020T, 237025T, 237030T, 238020T, 238025T, 238030T, 239020T… | 2004 | 15 |
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 5 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 21 ancestors have a recall of any class.
- Of its descendants, K032894 (Linvatec Biomaterials, Inc., 2004) has gone furthest, with 15 descendants of its own.
- 3 other devices also cite its predicate K955733.
How does its category compare?
All MAI devicesMAI Fastener, Fixation, Biodegradable, Soft Tissue: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MAI
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAI
54in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAI
40in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MAI
2,148in 2025
MAUDE reports naming product code MAI, 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 | 4 | 100 | 0 | 272 |
| 2008 | 3 | 83 | 0 | 172 |
| 2009 | 9 | 74 | 0 | 88 |
| 2010 | 4 | 122 | 0 | 89 |
| 2011 | 9 | 90 | 5 | 129 |
| 2012 | 6 | 56 | 10 | 171 |
| 2013 | 6 | 135 | 0 | 166 |
| 2014 | 4 | 86 | 0 | 149 |
| 2015 | 5 | 95 | 0 | 182 |
| 2016 | 3 | 191 | 0 | 301 |
| 2017 | 9 | 113 | 0 | 478 |
| 2018 | 13 | 108 | 0 | 1,590 |
| 2019 | 9 | 41 | 2 | 1,248 |
| 2020 | 9 | 78 | 40 | 957 |
| 2021 | 8 | 115 | 0 | 1,267 |
| 2022 | 6 | 136 | 0 | 1,425 |
| 2023 | 8 | 34 | 0 | 1,718 |
| 2024 | 7 | 53 | 0 | 2,300 |
| 2025 | 8 | 54 | 0 | 2,148 |
| 2026 | 5 | 69 | 1 | — |
What is it indicated for?
The SmartScrew ACL™ is intended for use in interference fixation of bone-patellar tendon — bone and soft tissue grafts in anterior and posterior cruciate ligament reconstructions.
The SmartScrew ACL™ is not intended for use in and is contraindicated for 1) cruciate ligament reconstructions, which would not be appropriate for fixation with metallic screws and 2) situations, where intra-articular replacement is otherwise contraindicated, e.g., active or potential infection and where patient cooperation cannot be guaranteed (e.g., alcoholism).
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/K993073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993073: Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993073
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