510(k) Report

510(k) · Cleared

Cleared

Z - Series Modular Total Hip System Plasma Coated

K040685510(k) TraditionalCleared Jan 25, 2005315-day reviewClass II21 CFR 888.3360

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

Osteoimplant Technology, Inc. · LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented

Cleared on Jan 25, 2005 after a 315-day review. FDA’s file for it is a 510(k) statement, which names no predicate.

Decided
Jan 25, 2005
Review
315 days
Class
Class II
Product code
LWJ
Recalls
None
Predicates
0

FDA’s file for it is a 510(k) statement, which names no predicate.

FIG. 1 — Lineage of K040685Source: FDA 510(k) database · How lineage is built

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

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LWJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

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.

How does its category compare?

All LWJ devices

LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · LWJ

1in 2012

2007: 22008: 12009: 12011: 12012: 1
2007high 2 (2007) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LWJ

Too few LWJ 510(k)s in any year since 2007 to give a median.

Recalls per year · LWJ

2in 2023

2007: 102008: 22009: 22013: 12023: 2
2007high 10 (2007) · low 0 (2010)2026

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

Adverse event reports per year · LWJ

51in 2025

2007: 682008: 722009: 842010: 1322011: 2552012: 3902013: 5222014: 4522015: 3102016: 2932017: 3112018: 2272019: 2102020: 1892021: 1552022: 912023: 722024: 542025: 51
2007high 522 (2013) · low 51 (2025)2025

MAUDE reports naming product code LWJ, 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
20072—1068
20081—272
20091—284
20100—0132
20111—0255
20121—0390
20130—1522
20140—0452
20150—0310
20160—0293
20170—0311
20180—0227
20190—0210
20200—0189
20210—0155
20220—091
20230—272
20240—054
20250—051
20260—0—

What is it indicated for?

The ZTM - Series Modular Total Hip System Plasma Coated is indicated for use in total or partial hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia…

Read the full statement (99 words)

The ZTM - Series Modular Total Hip System Plasma Coated is indicated for use in total or partial

hip replacement procedures for patients suffering severe pain and disability due to structural

damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen

disorders, avascular necrosis, traumatic and non-union of femoral fractures. Use of the

prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped

capital femoral epiphysis, and disability due to previous fusion, where bone stock is inadequate

for other reconstruction techniques.

CP Titanium Plasma Coated Implants are intended for Cement or Press Fit Applications.

Indications for use as stated in the FDA 510(k) statement.

More from Osteoimplant Technology, Inc.

21 FDA decisions under this applicant name. See the company

  • K041443Oti Alumina Ceramic Femoral Head SystemOsteoimplant Technology, Inc. · 2004
  • K040225Oti Alumina Ceramic Femoral Head SystemOsteoimplant Technology, Inc. · 2004
  • K032729Z-Series Modular Total Hip SystemOsteoimplant Technology, Inc. · 2003
  • K030608Oti Bone Cement PlugOsteoimplant Technology, Inc. · 20036 recalls
  • K022779Oti Unicondular Interpositional SpacerOsteoimplant Technology, Inc. · 2002

Recent decisions in LWJ

The LWJ category page

  • K120595Unisyn Plus Hip StemConsensus Orthopedics, Inc. · 2012
  • K103518Trinity Acetabular SystemCorin USA · 2011
  • K090764Novation CFS Press-Fit and Cemented StemsExactech, Inc. · 2009
  • K082146Metha Short Stem Hip System XL Femoral HeadAesculap Implant Systems, Inc. · 2008
  • K07006136MM Cocr Femoral Head and 36MM Acetabular InsertHayes Medical, Inc. · 2007

https://510kreport.com/device/K040685 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040685: Z - Series Modular Total Hip System Plasma Coated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040685

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Page last updated Nov 3, 2026