510(k) · Cleared

Recalled · 2005

Omega+ Compression Screw System

K955306510(k) TraditionalCleared Apr 10, 1996142-day reviewClass II21 CFR 888.3030Recalls 1

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

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

Cleared on Apr 10, 1996 as substantially equivalent to K850886 (Pfizer, Inc., 1985) and 3 other predicates after a 142-day review. Its family tree reaches back 1 generation to 1985. 15 later devices descend from it. It has been recalled once.

Decided: Apr 10, 1996
Review: 142 days
Class: Class II
Product code: KTT
Recalls: 1
Predicates: 4

Its longest line of descent runs back 1 generation to K850886 (1985). 4 ancestors in all. 15 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK850886 Compression Hip Screw SystemPfizer, Inc. · 1985 · Recalled
This deviceK955306 Omega+ Compression Screw SystemHowmedica Corp. · 1996
Descendant · cites it directly · 8 of its ownK970258 Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of…Ferguson Medical · 1997
Descendant · 2 generations on · 7 of its ownK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
Descendant · cites it directly · 3 of its ownK984331 Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999
Descendant · 2 generations on · 2 of its ownK033286 Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004
Descendant · 3 generations on · 1 of its ownK111352 Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

1997high 3 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 15 · See all

K970258Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck…Ferguson Medical · 1997 · cites it directly8descendants
K022139Hip Tool ImplantOrthopedic Sciences, Inc. · 2002 · 2 generations on7descendants
K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999 · cites it directly3descendants
K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004 · 2 generations on2descendants
K111352Talon Distalfix Proximal Femoral NailOrthopedic Designs North America, Inc. · 2011 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K850886	Compression Hip Screw System	Pfizer, Inc.	1985	1
0 (this device)	K955306	Omega+ Compression Screw System	Howmedica Corp.	1996	—
+1	K970258	Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable…	Ferguson Medical	1997	—
+2	K022139	Hip Tool Implant	Orthopedic Sciences, Inc.	2002	—
+1	K984331	Odi Ultimate Compression Hip Screw	Orthopedic Designs, Inc.	1999	—
+2	K033286	Odi Talon Long Proximal Femoral Nail System	Orthopedic Designs, Inc. (Odi)	2004	—
+3	K111352	Talon Distalfix Proximal Femoral Nail	Orthopedic Designs North America, Inc.	2011	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	1	0
1992	1	0
1994	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1997	3	0
1999	1	0
2002	1	0
2004	2	0
2005	3	0
2006	1	0
2007	2	0
2011	1	0
2023	1	0

FIG. 1 — Lineage of K955306, 1985–2023Source: 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 21.4 · 14 generations · no Class I recall
#2 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	Applicant	Decided	Recalls
*	K850886	Compression Hip Screw System Summary page 1 …ctures of the proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area). These components were previously released under K850886, K872223, K922295, and K930156. These components are now made avallable in sterlle packaging. It is Howmedica's intention to mark…	Pfizer, Inc.	1985	1
*	K872223	Modified Omega Compression Hip Screw System Summary page 1 …the proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area). These components were previously released under K850886, K872223, K922295, and K930156. These components are now made avallable in sterlle packaging. It is Howmedica's intention to market these…	Howmedica Corp.	1987	1
*	K922295	Omega Plus Compress Hip Screw System, Modification Summary page 1 …imal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area). These components were previously released under K850886, K872223, K922295, and K930156. These components are now made avallable in sterlle packaging. It is Howmedica's intention to market these products…	Howmedica Corp.	1992	1
*	K930156	Mega Plus Super Lag Screw Summary page 1 …ntracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area). These components were previously released under K850886, K872223, K922295, and K930156. These components are now made avallable in sterlle packaging. It is Howmedica's intention to market these products both sterile…	Pfizer Hospital Products Group, Inc.	1994	1

Also cleared against K850886: 2 other devices →

What descends from it? (15)

See all 15

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

Number	Device	Applicant	Decided	Descendants
K970258	Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck…	Ferguson Medical	1997	8
K984331	Odi Ultimate Compression Hip Screw	Orthopedic Designs, Inc.	1999	3
K971993	Odi Compression Hip Screw System	Orthopaedic Designs, Inc.	1997	0
K970280	Fixano D.S.S. (Double Sliding Screws) System for Osteosynthesis of Per-Trochanteroam…	Ferguson Medical	1997	0

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

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 25, 2005	Not classified	Z-1865-2008	Process control	Stryker Orthopaedics became aware that the packaging labeled as catalog number 3362-0-040; lot code E00985, 140 x 4 slot may contain a 5 hole slot.

No ancestor or descendant has a Class I recall.

What does this lineage say?

4 of the 4 ancestors have a recall of any class.
Of its descendants, K970258 (Ferguson Medical, 1997) has gone furthest, with 8 descendants of its own.
2 other devices also cite its predicate K850886.

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 Omega+ Compression Screw System consists of a series of lag screws, proximal hip sideplates, supracondylar side plates, and a compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric), and/or distal third of the femur (supracondylar area).

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/K955306 · printed Nov 4, 2026

Cite this page

510(k) Report. “K955306: Omega+ Compression Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955306

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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