510(k) · Cleared
Recalled · Class II · 2016Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini 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 Mar 31, 2015 as substantially equivalent to K090949 (Synthes (Usa), 2009) and 2 other predicates after a 148-day review. Its family tree reaches back 1 generation to 2002. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 31, 2015
- Review
- 148 days
- Class
- Class II
- Product code
- HWC
- Recalls
- 2
- Predicates
- 3
Its longest line of descent runs back 1 generation to K021556 (2002). 3 ancestors in all. 7 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK021556 Synthes 2.4 MM Cannulated Compression ScrewSynthes (Usa) · 2002
- This deviceK143165 Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw…Zimmer, Inc. · 2015
- Descendant · cites it directly · 4 of its ownK151407 RECON systemNormed Medizin-Technik GmbH · 2015
- Descendant · cites it directly · 2 of its ownK152312 RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH · 2015 · Recalled
- Descendant · 2 generations on · 1 of its ownK202657 Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK260277 Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 2026
- Descendant · 3 generations on · 0 of its ownK260291 Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc. · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K151407RECON systemNormed Medizin-Technik GmbH · 2015 · cites it directly4descendants
- K152312RECON system-V-TEK-IVP Plates and ScrewsNormed Medizin-Technik GmbH · 2015 · cites it directly2descendants
- K202657Javelin Tailor's Bunion Fixation SystemNvision Biomedical Technologies, Inc. · 2020 · 2 generations on1descendant
- K260277Mikron Trauma Bone Plate& Screw SystemMikron Makina San. ve Tic. Ltd. Sti. · 2026 · cites it directly0descendants
- K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021556 | Synthes 2.4 MM Cannulated Compression Screw | Synthes (Usa) | 2002 | — |
| 0 (this device) | K143165 | Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert… | Zimmer, Inc. | 2015 | — |
| +1 | K151407 | RECON system | Normed Medizin-Technik GmbH | 2015 | — |
| +1 | K152312 | RECON system-V-TEK-IVP Plates and Screws | Normed Medizin-Technik GmbH | 2015 | 4 |
| +2 | K202657 | Javelin Tailor's Bunion Fixation System | Nvision Biomedical Technologies, Inc. | 2020 | — |
| +1 | K260277 | Mikron Trauma Bone Plate& Screw System | Mikron Makina San. ve Tic. Ltd. Sti. | 2026 | — |
| +3 | K260291 | Vortex5 Tailor's Bunion Correction System | Nvision Biomedical Technologies, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2020 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K090949 | Synthes (Usa) 1.5MM Headless Compression ScrewsSummary page 4…8.3040, HWC) Classification Panel: Orthopedics/87 Predicate Device(s): Synthes 1.5mm Headless Compression Screws, manufactured by Synthes, K090949, cleared July 31, 2009, Synthes 2.4mm Headless Compression Screws, manufactured b… | 2009 |
| * | K021556 | Synthes 2.4 MM Cannulated Compression ScrewSummary page 4…ufactured by Synthes, K090949, cleared July 31, 2009, Synthes 2.4mm Headless Compression Screws, manufactured by Synthes, K021556, cleared August 9, 2002, Synthes 4.5mm and 6.5mm Headless Compression Screws, man… | 2002 |
| * | K080943 | Synthes 4.5 MM and 6.5 MM Headless Compression ScrewsSummary page 4…y Synthes, K021556, cleared August 9, 2002, Synthes 4.5mm and 6.5mm Headless Compression Screws, manufactured by Synthes, K080943, cleared April 23, 2008. Purpose and Device The Herbert devices are cannulated and non-cannulated D… | 2008 |
What descends from it? (7)
5 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 4, 2016 | Class II | Z-1680-2016 | Packaging change control | A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws. |
| Jan 11, 2016 | Class II | Z-1130-2016 | Packaging | As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. |
No ancestor or descendant has a 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. 2015, 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?
The Herbert™ Mini Bone Screw (2.5mm diameter, non-cannulated) and the Herbert™ Bone Screw (3.0mm diameter, non-cannulated) are indicated for fixation of intra-articular and extra-articular fractures, avulsions, non-union, and osteotomies of small bones and small bone fragments; as well as arthrodeses of small joints. The Herbert/Whipple® Bone Screw System (3.0mm diameter, cannulated) are indicated for the fixation of fractures and non-unions of small…
Read the full statement (143 words)
The Herbert™ Mini Bone Screw (2.5mm diameter, non-cannulated) and the Herbert™ Bone Screw (3.0mm diameter, non-cannulated) are indicated for fixation of intra-articular and extra-articular fractures, avulsions, non-union, and osteotomies of small bones and small bone fragments; as well as arthrodeses of small joints.
The Herbert/Whipple® Bone Screw System (3.0mm diameter, cannulated) are indicated for the fixation of fractures and non-unions of small bones and small bone arthrodeses, including, but not limited to, scaphoid fractures; intra-articular fractures of the tarsals, metatarsals, carpals and metacarpals; bunionectomies and osteotomies; arthrodeses of small joints (e.g. phalanges); fractures of the patella, ulna and radial styloid.
The Herbert™ Cannulated Bone Screw System (4.5mm and 6.5mm diameter) are indicated for fracture fixation, reconstruction, osteotomy, and arthrodesis of various bones and bone fragments including joint fusions (arthrodeses) in the foot and fixation of intra-articular fractures of the humerus, femur and tibia.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143165 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143165: Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini 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/K143165
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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