510(k) · Cleared

Cleared

Hoffmann II Compact Periarticular Clamp

K973321510(k) TraditionalCleared Nov 20, 199777-day reviewClass II21 CFR 888.3030

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

Howmedica, Inc. · KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Cleared on Nov 20, 1997 after a 77-day review. The FDA summary names its predicate without a number. 2 later devices descend from it.

Decided: Nov 20, 1997
Review: 77 days
Class: Class II
Product code: KTT
Recalls: None
Predicates: 0

2 later devices descend from it, 1 citing it directly.

This deviceK973321 Hoffmann II Compact Periarticular ClampHowmedica, Inc. · 1997
Descendant · cites it directly · 1 of its ownK071628 Stryker External Fixation SystemStryker Cmf · 2007
Descendant · 2 generations on · 0 of its ownK072764 KLS Martin Xternal FixatorKLS Martin L.P. · 2007

Most influential descendants

Showing 2 of 2 · See all

K071628Stryker External Fixation SystemStryker Cmf · 2007 · cites it directly1descendant
K072764KLS Martin Xternal FixatorKLS Martin L.P. · 2007 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K973321	Hoffmann II Compact Periarticular Clamp	Howmedica, Inc.	1997	—
+1	K071628	Stryker External Fixation System	Stryker Cmf	2007	—
+2	K072764	KLS Martin Xternal Fixator	KLS Martin L.P.	2007	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	2	0

FIG. 1 — Lineage of K973321, 1997–2007Source: 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 KTT? 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 KTT device

#1 K242861 TrueLok Elevatescore 21.3 · 14 generations · no Class I recall
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#3 Held for the reportin the report

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What was it cleared against? (4)

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	Recalls
*	—	Original Hoffmann® Small 4-Hole Ball Joint Named without a submission number	—
*	—	Hoffmann® II Compact External Fixation System Named without a submission number	—
*	—	Agee-Wristjack (Hand Biomechanics Lab, Inc) Named without a submission number	—
*	—	Radiolucent Wrist Fixation System (Orthofix) Named without a submission number	—

What descends from it? (2)

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

Number	Device	Applicant	Decided	Descendants
K071628	Stryker External Fixation System	Stryker Cmf	2007	1

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?

Of its descendants, K071628 (Stryker Cmf, 2007) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KTT devices

KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KTT

10in 2025

2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007high 14 (2018) · low 0 (2011)2026

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

Adverse event reports per year · KTT

673in 2025

2007high 961 (2021) · low 45 (2007)2025

MAUDE reports naming product code KTT, 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	9	55	2	45
2008	11	73	1	66
2009	11	94	2	45
2010	12	148	1	121
2011	10	157	0	196
2012	9	140	4	527
2013	7	87	7	898
2014	14	129	0	445
2015	12	60	0	401
2016	10	142	0	400
2017	11	184	1	485
2018	6	149	14	597
2019	8	110	3	800
2020	9	200	0	942
2021	10	83	2	961
2022	3	25	0	627
2023	7	29	0	554
2024	5	90	0	523
2025	10	88	0	673
2026	5	68	11	—

What is it indicated for?

The Periarticular Clamp is intended to be used with the components of the Hoffmann® II Compact External Fixation System and the Half Pins or Transfixing Pins of the Hoffmann® External Fixation System. It is intended to be used in the stabilization of open and/or unstable fractures and where soft tissue injury may preclude the use of other fracture treatments.

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/K973321 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973321: Hoffmann II Compact Periarticular Clamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973321

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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