510(k) · Cleared
ClearedHBS Headless Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Millennium Medical Technologies, Inc. · HWC Screw, Fixation, Bone
Cleared on Jun 6, 2002 as substantially equivalent to K792022 (Zimmer, Inc., 1979) and 1 other predicate after an 87-day review. Its family tree reaches back 1 generation to 1979. 1 of the 339 devices in its family, counting itself, has a Class I recall. 336 later devices descend from it.
- Decided
- Jun 6, 2002
- Review
- 87 days
- Class
- Class II
- Product code
- HWC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K792022 (1979). 2 ancestors in all. 336 later devices descend from it, 5 citing it directly. 1 of the 339 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
- This deviceK020791 HBS Headless Bone ScrewMillennium Medical Technologies, Inc. · 2002
- Descendant · cites it directly · 299 of its ownK024233 Kompressor Screw SystemKinetikos Medical, Inc. · 2003
- Descendant · 2 generations on · 255 of its ownK040356 Kompressor Screw SystemKinetikos Medical, Inc. · 2004
- Descendant · 3 generations on · 251 of its ownK060071 Nexa Compression ScrewNexa Orthopedics, Inc. · 2006
- Descendant · 4 generations on · 246 of its ownK063298 Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007
- Descendant · 5 generations on · 161 of its ownK111994 Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011
Showing 5 of 336 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub8 generations on · 2021
Most influential descendants
Showing 5 of 336 · See all- K024233Kompressor Screw SystemKinetikos Medical, Inc. · 2003 · cites it directly299descendants
- K040356Kompressor Screw SystemKinetikos Medical, Inc. · 2004 · 2 generations on255descendants
- K060071Nexa Compression ScrewNexa Orthopedics, Inc. · 2006 · 3 generations on251descendants
- K063298Osteomed Headless Cannulated Screw SystemOsteomed LP · 2007 · 4 generations on246descendants
- K111994Smith & Nephew Cannulated Screws and WashersSmith & Nephew, Inc. · 2011 · 5 generations on161descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | 6 |
| 0 (this device) | K020791 | HBS Headless Bone Screw | Millennium Medical Technologies, Inc. | 2002 | — |
| +1 | K024233 | Kompressor Screw System | Kinetikos Medical, Inc. | 2003 | — |
| +2 | K040356 | Kompressor Screw System | Kinetikos Medical, Inc. | 2004 | — |
| +3 | K060071 | Nexa Compression Screw | Nexa Orthopedics, Inc. | 2006 | — |
| +4 | K063298 | Osteomed Headless Cannulated Screw System | Osteomed LP | 2007 | — |
| +5 | K111994 | Smith & Nephew Cannulated Screws and Washers | Smith & Nephew, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 8 | 0 |
| 2012 | 7 | 0 |
| 2013 | 12 | 0 |
| 2014 | 10 | 0 |
| 2015 | 23 | 0 |
| 2016 | 11 | 0 |
| 2017 | 25 | 0 |
| 2018 | 8 | 0 |
| 2019 | 16 | 0 |
| 2020 | 19 | 0 |
| 2021 | 22 | 1 |
| 2022 | 23 | 0 |
| 2023 | 30 | 0 |
| 2024 | 32 | 0 |
| 2025 | 32 | 0 |
| 2026 | 43 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K792022 | Herbert Bone ScrewSummary page 1…rer. FCquivalent Device(s): HBS" HeadZess Bone Screw may be directly contrasted with the following equivalent devices: Zimmer HBSm, Zimmer, Inc., K792022 C a n n u l a t e d N a v i c u l a r Screw, Onyx Medical Corp. K931681 The Zimmer HBS is essentially identic… | 1979 |
| * | K931681 | Cannulated Navicular ScrewSummary page 1…h the following equivalent devices: Zimmer HBSm, Zimmer, Inc., K792022 C a n n u l a t e d N a v i c u l a r Screw, Onyx Medical Corp. K931681 The Zimmer HBS is essentially identical (clinically speaking) to the HBS" H e a d l e s s Bone Screw in terms of basic d… | 1994 |
What descends from it? (336)
See all 3365 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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?
Headless bone screw system for the fixation of osseous fragments or fractures including: HBS - MINI Scaphoid fractures Lunate fractures Capitate Trapezial fractures Metacarpal and metatarsal fractures Phalangeal fractures Radial head fractures Ulnar styloid fractures Osteo-chrondral Small joint fusions HBS - STANDARD Scaphoid fractures Carpal fractures & non-unions Capitellum fractures Metacarpal fractures Phalangeal fractures Distal radial fractures…
Read the full statement (89 words)
Headless bone screw system for the fixation of osseous fragments or fractures including:
HBS - MINI
Scaphoid fractures
Lunate fractures
Capitate
Trapezial fractures
Metacarpal and metatarsal fractures
Phalangeal fractures
Radial head fractures
Ulnar styloid fractures
Osteo-chrondral
Small joint fusions
HBS - STANDARD
Scaphoid fractures
Carpal fractures & non-unions
Capitellum fractures
Metacarpal fractures
Phalangeal fractures
Distal radial fractures
Radial head fractures
Ulnar styloid fractures
Small joint fusions
Humeral head fractures
Glenoid fractures
Intercarpal fusions
Interphalangeal fractures
Metatarsal osteotomies
Tarsal fusions
Malleolar fractures
Patellar fractures
Osteo-chrondral fractures
Odontoid fractures
Mandibular fractures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020791 · printed Nov 5, 2026
Cite this page
510(k) Report. “K020791: HBS Headless Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K020791
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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