510(k) · Cleared
Recalled · Class II · 2019Modification to HBS Headless Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biopro, Inc. · HWC Screw, Fixation, Bone
Cleared on Jun 3, 2010 as substantially equivalent to K020791 (Millennium Medical Technologies, Inc., 2002) and 2 other predicates after a 51-day review. Its family tree reaches back 2 generations to 1979. 40 later devices descend from it. It has been recalled 2 times.
- Decided
- Jun 3, 2010
- Review
- 51 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 2 generations to K792022 (1979). 5 ancestors in all. 40 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- 1 generation backK020791 HBS Headless Bone ScrewMillennium Medical Technologies, Inc. · 2002
- This deviceK101030 Modification to HBS Headless Bone ScrewBiopro, Inc. · 2010
- Descendant · cites it directly · 39 of its ownK120493 Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · Recalled
- Descendant · 2 generations on · 36 of its ownK123890 Acumed Cannulated Screw SystemAcumed, LLC · 2013 · Recalled
- Descendant · 3 generations on · 21 of its ownK190586 Monster® Screw SystemParagon 28, Inc. · 2019
- Descendant · 4 generations on · 9 of its ownK200398 AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020
- Descendant · 2 generations on · 9 of its ownK150693 PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K120493Mini Cannulated Headed and Headless Screw SetInstratek, Inc. · 2012 · cites it directly39descendants
- K123890Acumed Cannulated Screw SystemAcumed, LLC · 2013 · 2 generations on36descendants
- K190586Monster® Screw SystemParagon 28, Inc. · 2019 · 3 generations on21descendants
- K200398AxSOS 3 AF System and AxSOS 3 Ti SystemStryker GmbH · 2020 · 4 generations on9descendants
- K150693PHIN-FX Cannulated Lag Screw SystemAscent Medical, LLC · 2015 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| −1 | K020791 | HBS Headless Bone Screw | Millennium Medical Technologies, Inc. | 2002 | — |
| 0 (this device) | K101030 | Modification to HBS Headless Bone Screw | Biopro, Inc. | 2010 | — |
| +1 | K120493 | Mini Cannulated Headed and Headless Screw Set | Instratek, Inc. | 2012 | 1 |
| +2 | K123890 | Acumed Cannulated Screw System | Acumed, LLC | 2013 | 2 |
| +3 | K190586 | Monster® Screw System | Paragon 28, Inc. | 2019 | — |
| +4 | K200398 | AxSOS 3 AF System and AxSOS 3 Ti System | Stryker GmbH | 2020 | — |
| +2 | K150693 | PHIN-FX Cannulated Lag Screw System | Ascent Medical, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 1 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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? (3)
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 |
|---|---|---|---|
| * | K020791 | HBS Headless Bone ScrewSummary page 1…cation Name: Screw Fixation Bone Classification Panel: Orthopedic (OR) Regulatory Class: Class 11per 21 CFR §888.3390 Product Code: HWC Predicate Device: K020791; 510k 991197 Performance and Voluntary Standards No Performance Standards applicable to this device have been adopted under Sect… | 2002 |
| * | K991197 | Vilex/Duval/Orthex Cannulated Bone Screw, Models P222-XX, S25-XX, P227-XX, S30-XX…Summary page 1…Screw Fixation Bone Classification Panel: Orthopedic (OR) Regulatory Class: Class 11per 21 CFR §888.3390 Product Code: HWC Predicate Device: K020791; 510k 991197 Performance and Voluntary Standards No Performance Standards applicable to this device have been adopted under Section 514 of th… | 1999 |
| * | K010783 | 2.0/2.4 Cannulated Screw SystemSummary page 3…____________ _____ H HBS 510Ok 020791 Sizes Vilex 2.0-6.5mm 2.5-3.Omm.6mm to Osteomed K010783 2.0-2.4mm 40mm lengths HBS (original) 2.5-3.0mm up to 3… | 2001 |
What descends from it? (40)
See all 401 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120493 | Mini Cannulated Headed and Headless Screw Set | 2012 | 39 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2019 | Class II | Z-2259-2019 | Nonconforming Material/Component | Manufacturing flaw in the sterile barrier system |
| Jun 25, 2019 | Class II | Z-2239-2019 | Nonconforming Material/Component | Manufacturing flaw in the sterile barrier system |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 3 companies; a new generation was cleared every 22.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K120493 (Instratek, Inc., 2012) has gone furthest, with 39 descendants of its own.
- 4 other devices also cite its predicate K020791.
How does its category compare?
All HWC devicesHWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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?
HBS-Mini (2.5mm) — HIBS Standard (3.0mm)
Scaphoid fractures — Scaphoid fractures
Lunate fractures — Carpal fractures and non-unions
Capitate — Capitellum fractures
Trapezial fractures — Metacarpal fractures
Metacarpal and metatarsal fractures — Phalangeal fractures
Phalangeal fractures — Distal radial fractures
Radial head fractures — Radial head fractures
Ulnar styloid fractures — Ulnar styloid fractures
Osteo-chondral — Small joint fusions
Small joint fustions — Humeral head fractures
— Glenoid fractures
— Intercarpal fusions
— Interphalangeal fractures
— Metatarsal osteotomies
— Tarsal fusions
— Malleolar fractures
— Patellar fractures
— Osteo-chondral fractures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101030 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101030: Modification to HBS Headless Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101030
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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