510(k) Report

510(k) · Cleared

Recalled · 2005

Modified Omega Compression Hip Screw System

K872223510(k) TraditionalCleared Jun 26, 198717-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 Jun 26, 1987 after a 17-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it. It has been recalled once.

Decided
Jun 26, 1987
Review
17 days
Class
Class II
Product code
KTT
Recalls
1
Predicates
0

16 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 1996: 1 descendant cleared1999: 1 descendant cleared1997: 3 descendants cleared2004: 2 descendants cleared2011: 1 descendant cleared2002: 1 descendant cleared2005: 3 descendants cleared2007: 2 descendants cleared2023: 1 descendant cleared2006: 1 descendant cleared1990200020102020
  1. This deviceK872223 Modified Omega Compression Hip Screw SystemHowmedica Corp. · 1987
  2. Descendant · cites it directly · 15 of its ownK955306 Omega+ Compression Screw SystemHowmedica Corp. · 1996 · Recalled
  3. Descendant · 2 generations on · 8 of its ownK970258 Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of…Ferguson Medical · 1997
  4. Descendant · 3 generations on · 7 of its ownK022139 Hip Tool ImplantOrthopedic Sciences, Inc. · 2002
  5. Descendant · cites it directly · 3 of its ownK984331 Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc. · 1999
  6. Descendant · 2 generations on · 2 of its ownK033286 Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi) · 2004

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

1996: 11997: 31999: 12002: 12004: 22005: 32006: 12007: 22011: 12023: 1
1996high 3 (1997) · low 0 (1998)2026

Most influential descendants

Showing 5 of 16 · See all
  • K955306Omega+ Compression Screw SystemHowmedica Corp. · 1996 · cites it directly15descendants
  • K970258Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable Femoral Neck…Ferguson Medical · 1997 · 2 generations on8descendants
  • K022139Hip Tool ImplantOrthopedic Sciences, Inc. · 2002 · 3 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K872223Modified Omega Compression Hip Screw SystemHowmedica Corp.1987—
+1K955306Omega+ Compression Screw SystemHowmedica Corp.19961
+2K970258Fixano D.S.S. (Double Sliding Screws) System for Osteosynthsis of Unstable…Ferguson Medical1997—
+3K022139Hip Tool ImplantOrthopedic Sciences, Inc.2002—
+1K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc.1999—
+2K033286Odi Talon Long Proximal Femoral Nail SystemOrthopedic Designs, Inc. (Odi)2004—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199730
199910
200210
200420
200530
200610
200720
201110
202310
FIG. 1 — Lineage of K872223, 1987–2023Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K242861 TrueLok Elevatescore 21.4 · 14 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (16)

See all 16

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

NumberDeviceApplicantDecidedDescendants
K955306Omega+ Compression Screw SystemHowmedica Corp.199615
K984331Odi Ultimate Compression Hip ScrewOrthopedic Designs, Inc.19993
K971993Odi Compression Hip Screw SystemOrthopaedic Designs, Inc.19970

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

Recalls of this device

DateClassRecallRoot causeReason
Jan 25, 2005Not classifiedZ-1865-2008Process controlStryker 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?

  • Of its descendants, K955306 (Howmedica Corp., 1996) has gone furthest, with 15 descendants 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

2007: 92008: 112009: 112010: 122011: 102012: 92013: 72014: 142015: 122016: 102017: 112018: 62019: 82020: 92021: 102022: 32023: 72024: 52025: 102026 (partial year): 5
2007high 14 (2014) · low 3 (2022)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KTT

88in 2025

2007: 55 days median2008: 73 days median2009: 94 days median2010: 148 days median2011: 157 days median2012: 140 days median2013: 87 days median2014: 129 days median2015: 60 days median2016: 142 days median2017: 184 days median2018: 149 days median2019: 110 days median2020: 200 days median2021: 83 days median2022: 25 days median2023: 29 days median2024: 90 days median2025: 88 days median2026 (partial year): 68 days median
2007high 200 (2020) · low 25 (2022)2026

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

Recalls per year · KTT

2in 2021

2007: 22008: 12009: 22010: 12012: 42013: 72017: 12018: 142019: 32021: 22026 (partial year): 11
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

2007: 452008: 662009: 452010: 1212011: 1962012: 5272013: 8982014: 4452015: 4012016: 4002017: 4852018: 5972019: 8002020: 9422021: 9612022: 6272023: 5542024: 5232025: 673
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007955245
20081173166
20091194245
2010121481121
2011101570196
201291404527
20137877898
2014141290445
201512600401
2016101420400
2017111841485
2018614914597
201981103800
202092000942
202110832961
20223250627
20237290554
20245900523
202510880673
202656811—
Cite this page

510(k) Report. “K872223: Modified Omega Compression Hip 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/K872223

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026