# K143165: Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Mar 31, 2015 after 148 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021556 (2002). 3 ancestors in all.
7 later devices descend from it; 5 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090949: Synthes (Usa) 1.5MM Headless Compression Screws, Synthes (Usa) (2009) Summary page 4.
- K021556: Synthes 2.4 MM Cannulated Compression Screw, Synthes (Usa) (2002) Summary page 4.
- K080943: Synthes 4.5 MM and 6.5 MM Headless Compression Screws, Synthes (Usa) (2008) Summary page 4.

## Most influential descendants
- K151407: RECON system (2015), 4 descendants of its own
- K152312: RECON system-V-TEK-IVP Plates and Screws (2015), 2 descendants of its own
- K202657: Javelin Tailor's Bunion Fixation System (2020), 1 descendant of its own
- K260277: Mikron Trauma Bone Plate& Screw System (2026), 0 descendants of its own
- K260291: Vortex5 Tailor's Bunion Correction System (2026), 0 descendants of its own

## Recalls of this device
- May 4, 2016 · Class II · Z-1680-2016: 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: 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.

## Indications for use
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.

Source page: https://510kreport.com/device/K143165
Methodology: https://510kreport.com/methodology