510(k) · Cleared

Recalled · Class II · 2016

Synthes 6.5 MM Cannulated Screw

K021932510(k) TraditionalCleared Sep 6, 200286-day reviewClass II21 CFR 888.3040Recalls 7

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

Synthes (Usa) · HWC Screw, Fixation, Bone

Cleared on Sep 6, 2002 after an 86-day review. The FDA summary names its predicate without a number. 1 of the 756 devices in its family, counting itself, has a Class I recall. 755 later devices descend from it. It has been recalled 7 times.

Decided: Sep 6, 2002
Review: 86 days
Class: Class II
Product code: HWC
Recalls: 7
Predicates: 0

755 later devices descend from it, 62 citing it directly. 1 of the 756 devices in this family, counting this one, has a Class I recall.

This deviceK021932 Synthes 6.5 MM Cannulated ScrewSynthes (Usa) · 2002
Descendant · cites it directly · 309 of its ownK102903 Pioneer Cannulated Screw SystemPioneer Surgical Technology, Inc. · 2010
Descendant · cites it directly · 245 of its ownK102907 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010
Descendant · 2 generations on · 241 of its ownK110512 Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
Descendant · 3 generations on · 240 of its ownK111801 Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011
Descendant · cites it directly · 238 of its ownK112028 SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011

Showing 5 of 755 descendants. See all descendants

Descendants cleared per year

2005high 89 (2026) · low 0 (2006)2026

Class I recalls in this family

K211616 ExcelsiusHub3 generations on · 2021

Most influential descendants

Showing 5 of 755 · See all

K102903Pioneer Cannulated Screw SystemPioneer Surgical Technology, Inc. · 2010 · cites it directly309descendants
K102907Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2010 · cites it directly245descendants
K110512Simmetry Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011 · 2 generations on241descendants
K111801Simmetry (TM) Sacroiliac Joint Fusion SystemZyga Technology, Inc. · 2011 · 3 generations on240descendants
K112028SI-Lok Sacroiliac Joint Fixation SystemGlobus Medical, Inc. · 2011 · cites it directly238descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K021932	Synthes 6.5 MM Cannulated Screw	Synthes (Usa)	2002	—
+1	K102903	Pioneer Cannulated Screw System	Pioneer Surgical Technology, Inc.	2010	—
+1	K102907	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2010	—
+2	K110512	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2011	—
+3	K111801	Simmetry (TM) Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2011	—
+1	K112028	SI-Lok Sacroiliac Joint Fixation System	Globus Medical, Inc.	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	2	0
2008	2	0
2009	2	0
2010	6	0
2011	15	0
2012	10	0
2013	19	0
2014	19	0
2015	34	0
2016	19	0
2017	48	0
2018	23	0
2019	34	0
2020	52	0
2021	58	1
2022	71	0
2023	85	0
2024	82	0
2025	85	0
2026	89	0

FIG. 1 — Lineage of K021932, 2002–2026Source: 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.

1 device in this family has a Class I recall. 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

Get a 510(k) Report

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
*	—	Synthes 7.3 mm Cannulated Screw Named without a submission number			—
*	—	Alphatec 6.5 Cannulated Screw Named without a submission number			—

What descends from it? (755)

See all 755

62 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K102903	Pioneer Cannulated Screw System	Pioneer Surgical Technology, Inc.	2010	309
K102907	Simmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2010	245
K112028	SI-Lok Sacroiliac Joint Fixation System	Globus Medical, Inc.	2011	238
K102343	Emerge Medical Cannulated Screw Fixation System	Emerge Medical	2010	220
K082874	Biodrive Cannulated Screw System	Biomet Trauma	2009	168
K111994	Smith & Nephew Cannulated Screws and Washers	Smith & Nephew, Inc.	2011	161
K080398	SI Joint Fusion System	SI-BONE, Inc.	2008	144
K110472	SI-Fix Sacroiliac Joint Fusion System	Medtronic Sofamor Danek	2012	92
K141549	SImmetry Sacroiliac Joint Fusion System	Zyga Technology, Inc.	2015	63
K123702	Silex Sacroiliac Joint Fusion System	X-Spine Systems, Inc.	2013	49

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Feb 16, 2016	Class II	Z-2156-2016	Labeling False and Misleading	Labeling does not match the cleared indications for use in the United States and Canada.
Feb 16, 2016	Class II	Z-2153-2016	Labeling False and Misleading	Labeling does not match the cleared indications for use in the United States and Canada.
Feb 16, 2016	Class II	Z-2154-2016	Labeling False and Misleading	Labeling does not match the cleared indications for use in the United States and Canada.
Feb 16, 2016	Class II	Z-2155-2016	Labeling False and Misleading	Labeling does not match the cleared indications for use in the United States and Canada.
Feb 16, 2016	Class II	Z-2157-2016	Labeling False and Misleading	Labeling does not match the cleared indications for use in the United States and Canada.
Feb 16, 2016	Class II	Z-2152-2016	Labeling False and Misleading	Labeling does not match the cleared indications for use in the United States and Canada.
Feb 16, 2016	Class II	Z-2158-2016	Labeling False and Misleading	Labeling does not match the cleared indications for use in the United States and Canada.

The 5 latest of 7 recalls; the web page lists all.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

Of its descendants, K102903 (Pioneer Surgical Technology, Inc., 2010) has gone furthest, with 309 descendants of its own.

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?

Synthes 6.5 mm Cannulated Screw is intended for fracture fixation of large bones and large bone fragments, such as femoral neck fractures; slipped capital femoral epiphyses; an adjunct to DHS in basilar neck fractures; tibial plateau fractures; ankle arthrodeses; pediatric femoral neck fractures; intercondylar femur fractures; SI joint disruptions; and subtalar arthrodeses.

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/K021932 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021932: Synthes 6.5 MM Cannulated Screw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021932

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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