# K990622: Bold Screw

- Pathway: 510(k) (Traditional)
- Applicant: New Deal, S.A.
- Decided: Apr 29, 1999 after 63 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K792022 (1979). 2 ancestors in all.
5 later devices descend from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931155: Staple, Fixation Bone; Screw Fixation Bone, Roseburg SA (1994) Summary page 2.
- K792022: Herbert Bone Screw, Zimmer, Inc. (1979) Summary page 2.

## Most influential descendants
- K070617: Cannulated Screw (2007), 4 descendants of its own
- K170040: BePOD Cannulated Arthrodesis Screws (2017), 0 descendants of its own
- K151241: Synchro-Medical TIGER TRACK Screw System (2015), 0 descendants of its own
- K150471: CalcaNail Orthopedic Arthrodesis Nail (2015), 0 descendants of its own
- K150463: CalcaNail Orthopedic Nail (2015), 0 descendants of its own

## Recalls of this device
- Nov 10, 2006 · Not classified · Z-0466-2007: Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.

## Indications for use
The BOLD® SCREW is indicated for fixing the electivc osteotomics of the mid-foot bones and the metatarsal and phalanges of the foot only. Examples include: & Mono or Bi-cortical osteotomies in the forefoot ® Distal or proximal metatarsal osteotomics ® Wcil osteotomy ® Fusion of the first metatarsophalangeal joint and interphalangeal joint, e Fixation of osteotornies for Hallux Valgus treatment (such as Scarf, Chevron, ...etc.) & Akin type ostcotomy e Arthrodesis base first metatarsal cuneiform joint to rcposition and stabilize metatarsus varus primus

Source page: https://510kreport.com/device/K990622
Methodology: https://510kreport.com/methodology