510(k) · Cleared
ClearedBio-Core Interference Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomet, Inc. · HWC Screw, Fixation, Bone
Cleared on Dec 14, 2004 as substantially equivalent to K041274 (Arthrotek, Inc., 2004) and 3 other predicates after an 85-day review. Its family tree reaches back 3 generations to 1995. 4 later devices descend from it.
- Decided
- Dec 14, 2004
- Review
- 85 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K943806 (1995). 14 ancestors in all, the oldest K931519 (1994). 4 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK943806 Harpoon Suture AnchorsBiomet, Inc. · 1995
- 2 generations backK012872 Resorbable Screw AnchorArthrotek, Inc. · 2001
- 1 generation backK041274 Resorbable Interference ScrewArthrotek, Inc. · 2004 · Recalled
- This deviceK042552 Bio-Core Interference ScrewBiomet, Inc. · 2004
- Descendant · cites it directly · 1 of its ownK140879 Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc. · 2014
- Descendant · cites it directly · 1 of its ownK071464 Inion Hexalon Biodegradable Acl/PCL ScrewInion OY · 2007
- Descendant · 2 generations on · 0 of its ownK142948 BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc. · 2015 · Recalled
- Descendant · 2 generations on · 0 of its ownK130716 Bioretec Activascrew InterferenceBioretec, Ltd. · 2013
Most influential descendants
Showing 4 of 4 · See all- K140879Biosure Healicoil PK Interference ScrewSmith & Nephew, Inc. · 2014 · cites it directly1descendant
- K071464Inion Hexalon Biodegradable Acl/PCL ScrewInion OY · 2007 · cites it directly1descendant
- K142948BIOSURE REGENESORB interference ScrewSmith & Nephew, Inc. · 2015 · 2 generations on0descendants
- K130716Bioretec Activascrew InterferenceBioretec, Ltd. · 2013 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943806 | Harpoon Suture Anchors | Biomet, Inc. | 1995 | — |
| −2 | K012872 | Resorbable Screw Anchor | Arthrotek, Inc. | 2001 | — |
| −1 | K041274 | Resorbable Interference Screw | Arthrotek, Inc. | 2004 | 5 |
| 0 (this device) | K042552 | Bio-Core Interference Screw | Biomet, Inc. | 2004 | — |
| +1 | K140879 | Biosure Healicoil PK Interference Screw | Smith & Nephew, Inc. | 2014 | — |
| +1 | K071464 | Inion Hexalon Biodegradable Acl/PCL Screw | Inion OY | 2007 | — |
| +2 | K142948 | BIOSURE REGENESORB interference Screw | Smith & Nephew, Inc. | 2015 | 1 |
| +2 | K130716 | Bioretec Activascrew Interference | Bioretec, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 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? (4)
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 |
|---|---|---|---|
| * | K041274 | Resorbable Interference ScrewSummary page 1…Screw, Fixation, Bone (21 CFR §888.3040) Legally Marketed Devices to Which Substantial Equivalence Is Claimed: Resorbable Interference Screw -Arthrotek, Inc. (K041274) Bone Mulch System - Biomnet, Inc. (K993025, K991298, K94 194 1) Device Descri… | 2004 |
| * | K993025 | Modification to Bone Mulch Screw SystemSummary page 1…Devices to Which Substantial Equivalence Is Claimed: Resorbable Interference Screw -Arthrotek, Inc. (K041274) Bone Mulch System - Biomnet, Inc. (K993025, K991298, K94 194 1) Device Description: The implant consists of a LactoSorb (85% PLLAI15%… | 1999 |
| * | K991298 | Bone Mulch Screw SystemSummary page 1…o Which Substantial Equivalence Is Claimed: Resorbable Interference Screw -Arthrotek, Inc. (K041274) Bone Mulch System - Biomnet, Inc. (K993025, K991298, K94 194 1) Device Description: The implant consists of a LactoSorb (85% PLLAI15% PGA)… | 1999 |
| * | K941941 | Bone Mulch ScrewSummary page 1…Claimed: Resorbable Interference Screw -Arthrotek, Inc. (K041274) Bone Mulch System - Biomnet, Inc. (K993025, K991298, K94 194 1) Device Description: The implant consists of a LactoSorb (85% PLLAI15% PGA) interf… | 1995 |
What descends from it? (4)
2 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 9 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 3 of the 14 ancestors have a recall of any class.
- Of its descendants, K140879 (Smith & Nephew, Inc., 2014) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K041274.
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?
Indications for the Bio-CoreTM Interference Screw include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications include the following: Shoulder: Bankart repair, SLAP lesion repair, acromio-ciavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral…
Read the full statement (186 words)
Indications for the Bio-CoreTM Interference Screw include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications include the following:
Shoulder: Bankart repair, SLAP lesion repair, acromio-ciavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.
Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, hallux valgus reconstruction, mid- and forefoot reconstruction.
Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.
Knee: Extra-capsular repair, medial collateral ligament (MCL) repair, lateral collateral ligament (LCL) repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tenodesis reconstruction, patellar ligament/tendon repair, and vastus medialis obliquus (VMO) muscle advancement.
In addition to the above indications, the 7.0, 8.0, 9.0, 10.0, 11.0, and 12.0 mm screws are indicated for the following uses:
1. To provide interference fixation of patellar bone-tendon-bone grafts in anterior cruciate ligament (ACL) reconstruction.
2. To provide interference fixation during femoral and/or tibial fixation in anterior cruciate ligament reconstruction using a soft tissue graft (semitendinosus, gracilis).
3. To provide interference fixation during posterior cruciate ligament (PCL) reconstruction.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042552 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042552: Bio-Core Interference Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042552
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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