510(k) · Cleared
Recalled · Class II · 2013Herbert Bone Screw
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zimmer, Inc. · HWC Screw, Fixation, Bone
Cleared on Oct 26, 1979 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 989 devices in its family, counting itself, has a Class I recall. 988 later devices descend from it. It has been recalled 6 times.
- Decided
- Oct 26, 1979
- Review
- 17 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 6
- Predicates
- 0
988 later devices descend from it, 18 citing it directly. 1 of the 989 devices in this family, counting this one, has a Class I recall.
- This deviceK792022 Herbert Bone ScrewZimmer, Inc. · 1979
- Descendant · cites it directly · 548 of its ownK962236 Scarf Thread-Head ScrewLandos, Inc. · 1996
- Descendant · 2 generations on · 527 of its ownK062352 FRS ScrewDePuy Orthopaedics, Inc. · 2006
- Descendant · 3 generations on · 487 of its ownK090675 Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009
- Descendant · cites it directly · 419 of its ownK974876 Bionx Distal Radius ScrewBionx Implants, Inc. · 1998
- Descendant · 2 generations on · 413 of its ownK992947 Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999
Showing 5 of 988 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 988 · See all- K962236Scarf Thread-Head ScrewLandos, Inc. · 1996 · cites it directly548descendants
- K062352FRS ScrewDePuy Orthopaedics, Inc. · 2006 · 2 generations on527descendants
- K090675Smith & Nephew, Inc. VLP Foot Plating, Screw System and AccessoriesSmith & Nephew, Inc. · 2009 · 3 generations on487descendants
- K974876Bionx Distal Radius ScrewBionx Implants, Inc. · 1998 · cites it directly419descendants
- K992947Cannulated Smartscrew Models 224540C, 224570CBionx Implants, Ltd. · 1999 · 2 generations on413descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K792022 | Herbert Bone Screw | Zimmer, Inc. | 1979 | — |
| +1 | K962236 | Scarf Thread-Head Screw | Landos, Inc. | 1996 | — |
| +2 | K062352 | FRS Screw | DePuy Orthopaedics, Inc. | 2006 | — |
| +3 | K090675 | Smith & Nephew, Inc. VLP Foot Plating, Screw System and Accessories | Smith & Nephew, Inc. | 2009 | — |
| +1 | K974876 | Bionx Distal Radius Screw | Bionx Implants, Inc. | 1998 | — |
| +2 | K992947 | Cannulated Smartscrew Models 224540C, 224570C | Bionx Implants, Ltd. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 8 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 10 | 0 |
| 2009 | 15 | 0 |
| 2010 | 9 | 0 |
| 2011 | 21 | 0 |
| 2012 | 23 | 0 |
| 2013 | 30 | 0 |
| 2014 | 47 | 0 |
| 2015 | 49 | 0 |
| 2016 | 29 | 0 |
| 2017 | 67 | 0 |
| 2018 | 38 | 0 |
| 2019 | 64 | 0 |
| 2020 | 62 | 0 |
| 2021 | 64 | 1 |
| 2022 | 65 | 0 |
| 2023 | 79 | 0 |
| 2024 | 86 | 0 |
| 2025 | 89 | 0 |
| 2026 | 94 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (988)
See all 98818 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K962236 | Scarf Thread-Head Screw | 1996 | 548 |
| K974876 | Bionx Distal Radius Screw | 1998 | 419 |
| K020791 | HBS Headless Bone Screw | 2002 | 336 |
| K063298 | Osteomed Headless Cannulated Screw System | 2007 | 246 |
| K050681 | Omnitech System & Easy Lock Osteosystem with Xtremities Plates | 2005 | 92 |
| K030706 | Ebi Dynafix Compression Bone Screw | 2003 | 69 |
| K960533 | K3 Bone Screw System | 1996 | 61 |
| K960537 | K2 Bone Screw System | 1996 | 41 |
| K990622 | Bold Screw | 1999 | 5 |
| K083144 | Acumed Clavicle Screw System | 2009 | 1 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 11, 2013 | Class II | Z-1038-2014 | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the… |
| Oct 11, 2013 | Class II | Z-1002-2014 | Packaging | Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the… |
| Jun 26, 2006 | Not classified | Z-1349-06 | Other | Lack of assurance of sterility, as the sterile barrier packaging may have been compromised. |
| Jun 26, 2006 | Not classified | Z-1350-06 | Other | Lack of assurance of sterility, as the sterile barrier packaging may have been compromised. |
| Jun 26, 2006 | Not classified | Z-1348-06 | Other | Lack of assurance of sterility, as the sterile barrier packaging may have been compromised. |
| Jun 26, 2006 | Not classified | Z-1351-06 | Other | Lack of assurance of sterility, as the sterile barrier packaging may have been compromised. |
The 5 latest of 6 recalls; the web page lists all.
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K962236 (Landos, Inc., 1996) has gone furthest, with 548 descendants of its own.
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 | — |
https://510kreport.com/device/K792022 · printed Nov 4, 2026
Cite this page
510(k) Report. “K792022: Herbert Bone Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K792022
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026