510(k) · Cleared
ClearedBio-Intrafix Tibial Screw and Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mitek Worldwide · HWC Screw, Fixation, Bone
Cleared on Oct 15, 2003 as substantially equivalent to K983560 (Innovasive Devices, Inc., 1999) and 1 other predicate after a 91-day review. Its family tree reaches back 4 generations to 1997. 15 later devices descend from it.
- Decided
- Oct 15, 2003
- Review
- 91 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K971358 (1997). 7 ancestors in all. 15 later devices descend from it, 4 citing it directly.
- Root · 4 generations backK971358 Bio-Interference Screw, 7 MM, 8 MM, 9 MMArthrex, Inc. · 1997
- 3 generations backK990454 Bio-Interference ScrewInnovasive Devices, Inc. · 1999
- 2 generations backK993975 Absolute Absorbable Interference ScrewInnovasive Devices, Inc. · 1999
- 1 generation backK013572 Mitek Biocryl Interference ScrewsMitek Products · 2002
- This deviceK032167 Bio-Intrafix Tibial Screw and SheathMitek Worldwide · 2003
- Descendant · cites it directly · 7 of its ownK063577 Femoral Intrafix Screw and SheathJohnson & Johnson Company · 2007
- Descendant · 2 generations on · 5 of its ownK122123 6-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek…Depuy Mitek, Inc., A Johnson and Johnson Company · 2012
- Descendant · 3 generations on · 4 of its ownK130539 Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013
- Descendant · 4 generations on · 3 of its ownK131683 Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013
- Descendant · cites it directly · 3 of its ownK093912 Arthrex Tibial GraftboltArthrex, Inc. · 2010
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K063577Femoral Intrafix Screw and SheathJohnson & Johnson Company · 2007 · cites it directly7descendants
- K1221236-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered Screw…Depuy Mitek, Inc., A Johnson and Johnson Company · 2012 · 2 generations on5descendants
- K130539Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM)Depuy Mitek, A Johnson & Johnson Company · 2013 · 3 generations on4descendants
- K131683Healix Advance Knotless Peek Anchor (6.5MM)Depuy Mitek, Inc., A Johnson and Johnson Company · 2013 · 4 generations on3descendants
- K093912Arthrex Tibial GraftboltArthrex, Inc. · 2010 · cites it directly3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K971358 | Bio-Interference Screw, 7 MM, 8 MM, 9 MM | Arthrex, Inc. | 1997 | — |
| −3 | K990454 | Bio-Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −2 | K993975 | Absolute Absorbable Interference Screw | Innovasive Devices, Inc. | 1999 | — |
| −1 | K013572 | Mitek Biocryl Interference Screws | Mitek Products | 2002 | — |
| 0 (this device) | K032167 | Bio-Intrafix Tibial Screw and Sheath | Mitek Worldwide | 2003 | — |
| +1 | K063577 | Femoral Intrafix Screw and Sheath | Johnson & Johnson Company | 2007 | — |
| +2 | K122123 | 6-8MM X 30 MM Intrafix Peek Tapered Screw 7-9MM X 30MM Intrafix Peek Tapered… | Depuy Mitek, Inc., A Johnson and Johnson Company | 2012 | — |
| +3 | K130539 | Healix Advance Knotless Peek Anchor (4.75MM)(5.5MM) | Depuy Mitek, A Johnson & Johnson Company | 2013 | — |
| +4 | K131683 | Healix Advance Knotless Peek Anchor (6.5MM) | Depuy Mitek, Inc., A Johnson and Johnson Company | 2013 | — |
| +1 | K093912 | Arthrex Tibial Graftbolt | Arthrex, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K983560 | Innovasive Devices Intratunnel Tibial Fixation FastenerSummary page 1…The predicate devices used to determine substantial equivalence for the Mitek’s Bio-INTRAFIX Tibial Screw and Sheaths are IntraFIX (K983560) and Biocryl Interference Screws (KO1 3572) currently marketed by Mitek Worldwide, Nonvood, MA 02062. 4. DEVICE… | 1999 |
| * | K013572 | Mitek Biocryl Interference Screws | 2002 |
What descends from it? (15)
See all 154 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 6 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K063577 (Johnson & Johnson Company, 2007) has gone furthest, with 7 descendants of its own.
- 6 other devices also cite its predicate K983560.
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 Bio-INTRAFIX Tibial Tapered Screw and Sheath are indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032167 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032167: Bio-Intrafix Tibial Screw and Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032167
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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