510(k) · Cleared

Recalled · 2006

Bold Screw

K990622510(k) TraditionalCleared Apr 29, 199963-day reviewClass II21 CFR 888.3040Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

New Deal, S.A. · HWC Screw, Fixation, Bone

Cleared on Apr 29, 1999 as substantially equivalent to K931155 (Roseburg SA, 1994) and 1 other predicate after a 63-day review. Its family tree reaches back 1 generation to 1979. 5 later devices descend from it. It has been recalled once.

Decided: Apr 29, 1999
Review: 63 days
Class: Class II
Product code: HWC
Recalls: 1
Predicates: 2

Its longest line of descent runs back 1 generation to K792022 (1979). 2 ancestors in all. 5 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK792022 Herbert Bone ScrewZimmer, Inc. · 1979 · Recalled
This deviceK990622 Bold ScrewNew Deal, S.A. · 1999
Descendant · cites it directly · 4 of its ownK070617 Cannulated ScrewFournitures Hospitalieres Industrie · 2007
Descendant · 2 generations on · 0 of its ownK170040 BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie · 2017
Descendant · 2 generations on · 0 of its ownK151241 Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015
Descendant · 2 generations on · 0 of its ownK150471 CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie · 2015
Descendant · 2 generations on · 0 of its ownK150463 CalcaNail Orthopedic NailFournitures Hospitalieres Industrie · 2015

Most influential descendants

Showing 5 of 5 · See all

K070617Cannulated ScrewFournitures Hospitalieres Industrie · 2007 · cites it directly4descendants
K170040BePOD Cannulated Arthrodesis ScrewsFournitures Hospitalieres Industrie · 2017 · 2 generations on0descendants
K151241Synchro-Medical TIGER TRACK Screw SystemSynchro Medical · 2015 · 2 generations on0descendants
K150471CalcaNail Orthopedic Arthrodesis NailFournitures Hospitalieres Industrie · 2015 · 2 generations on0descendants
K150463CalcaNail Orthopedic NailFournitures Hospitalieres Industrie · 2015 · 2 generations on0descendants

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)	K990622	Bold Screw	New Deal, S.A.	1999	—
+1	K070617	Cannulated Screw	Fournitures Hospitalieres Industrie	2007	—
+2	K170040	BePOD Cannulated Arthrodesis Screws	Fournitures Hospitalieres Industrie	2017	—
+2	K151241	Synchro-Medical TIGER TRACK Screw System	Synchro Medical	2015	—
+2	K150471	CalcaNail Orthopedic Arthrodesis Nail	Fournitures Hospitalieres Industrie	2015	—
+2	K150463	CalcaNail Orthopedic Nail	Fournitures Hospitalieres Industrie	2015	—

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
2007	1	0
2015	3	0
2017	1	0

FIG. 1 — Lineage of K990622, 1979–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K931155	Staple, Fixation Bone; Screw Fixation Bone Summary page 2 …first metatarsal cunciform joint to reposition and stabilize metatarsus varus primus The BOLD® SCREW is substantially equivalent to the Scarf Thread-head Screw (DePuy) (K931155) and the Herbert-Whipple Bone Screw (Zimmer) (K792022) Both the BOLD® SCREW, the Scarf Thread-head Screw and the Herbert-Whipple…	Roseburg SA	1994	—
*	K792022	Herbert Bone Screw Summary page 2 …bilize metatarsus varus primus The BOLD® SCREW is substantially equivalent to the Scarf Thread-head Screw (DePuy) (K931155) and the Herbert-Whipple Bone Screw (Zimmer) (K792022) Both the BOLD® SCREW, the Scarf Thread-head Screw and the Herbert-Whipple Bone Screw have the same intended use and all are ind…	Zimmer, Inc.	1979	6

Also cleared against K931155: 2 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K070617	Cannulated Screw	Fournitures Hospitalieres Industrie	2007	4

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Nov 10, 2006	Not classified	Z-0466-2007	Other	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.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K070617 (Fournitures Hospitalieres Industrie, 2007) has gone furthest, with 4 descendants of its own.
2 other devices also cite its predicate K931155.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HWC

15in 2025

2007high 41 (2015) · low 15 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HWC

111in 2025

2007high 167 (2022) · low 75 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · HWC

1in 2025

2007high 33 (2008) · low 0 (2023)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · HWC

2,893in 2025

2007high 5,463 (2019) · low 651 (2009)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 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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K990622 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990622: Bold Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990622

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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