510(k) · Cleared

Cleared

Cannulated Compression Device System

K210146510(k) TraditionalCleared Apr 13, 2022447-day reviewClass II21 CFR 888.3040

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

Orthopedic Designs North America, Inc. · HWC Screw, Fixation, Bone

Cleared on Apr 13, 2022 as substantially equivalent to K000080 (Howmedica Osteonics Corp., 2000) and 2 other predicates after a 447-day review. Its family tree reaches back 1 generation to 2000.

Decided: Apr 13, 2022
Review: 447 days
Class: Class II
Product code: HWC
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K000080 (2000). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK000080 Asnis Iii Cannulated Screw SystemHowmedica Osteonics Corp. · 2000 · Recalled
This deviceK210146 Cannulated Compression Device SystemOrthopedic Designs North America, Inc. · 2022

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K000080	Asnis Iii Cannulated Screw System	Howmedica Osteonics Corp.	2000	1
0 (this device)	K210146	Cannulated Compression Device System	Orthopedic Designs North America, Inc.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2008	1	0

FIG. 1 — Lineage of K210146, 2000–2022Source: 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? (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	Applicant	Decided	Recalls
*	K000080	Asnis Iii Cannulated Screw System Summary page 4 …HWC Proposed Regulatory Class: Class II Predicate Devices: Primary: Stryker® Asnis® III Cannulated Screw System (K000080) Additional: Synthes® (USA) 6.5 mm Cannulated Screw (K021932) Synthes® (USA) 4.5 and 6.5 mm He…	Howmedica Osteonics Corp.	2000	1
*	K021932	Synthes 6.5 MM Cannulated Screw Summary page 4 …evices: Primary: Stryker® Asnis® III Cannulated Screw System (K000080) Additional: Synthes® (USA) 6.5 mm Cannulated Screw (K021932) Synthes® (USA) 4.5 and 6.5 mm Headless Compression Screws (K080943) Device De…	Synthes (Usa)	2002	7
*	K080943	Synthes 4.5 MM and 6.5 MM Headless Compression Screws Summary page 4 …Additional: Synthes® (USA) 6.5 mm Cannulated Screw (K021932) Synthes® (USA) 4.5 and 6.5 mm Headless Compression Screws (K080943) Device Description: The Cannulated Compression Device System is used to aid in the alignment and stabilization of bon…	Synthes (Usa)	2008	—

Also cleared against K000080: 20 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

2 of the 3 ancestors have a recall of any class.
20 other devices also cite its predicate K000080.

How does its category compare?

All HWC devices

HWC Screw, Fixation, Bone: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

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 Cannulated Compression Device System is indicated for fracture fixation of small and long bones. The system is not intended for spinal use.

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/K210146 · printed Nov 6, 2026

Cite this page

510(k) Report. “K210146: Cannulated Compression Device System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210146

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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