Z - Series Modular Total Hip System Plasma Coated
FDA 510(k) K040685 · Osteoimplant Technology, Inc.
510(k) numberK040685
Submission
- Device name
- Z - Series Modular Total Hip System Plasma Coated
- Applicant
- Osteoimplant Technology, Inc.
Hunt Valley, MD, US - Received
- March 16, 2004
- Decision date
- January 25, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3360
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code LWJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120595 | Unisyn Plus Hip StemLWJ · Traditional | Consensus Orthopedics, Inc. | 10/12/2012SE |
| K103518 | Trinity Acetabular SystemLWJ · Traditional | Corin USA | 03/09/2011SE |
| K090764 | Novation CFS Press-Fit and Cemented StemsLWJ · Special | Exactech, Inc. | 04/21/2009SE |
| K082146 | Metha Short Stem Hip System XL Femoral HeadLWJ · Special | Aesculap Implant Systems, Inc. | 09/09/2008SE |
| K070061 | 36MM Cocr Femoral Head and 36MM Acetabular InsertLWJ · Special | Hayes Medical, Inc. | 01/31/2007SE |
| K062978 | U2 Hip Stem, Ti Plasma SprayLWJ · Traditional | United Orthopedic Corp. | 01/16/2007SE |
| K062383 | Unisyn Ha Plasma Modular HipLWJ · Special | Hayes Medical, Inc. | 12/21/2006SE |
| K061699 | ExciaLWJ · Special | Aesculap, Inc. | 08/18/2006SE |
| K051826 | Betacone Hip Prosthesis SystemLWJ · Traditional | Waldemar Link GmbH & Co. KG | 11/18/2005SE |
| K050262 | U2 Acetabular ComponentLWJ · Traditional | United Orthopedic Corp. | 08/15/2005SE |
More from United Orthopedic Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K041443 | Oti Alumina Ceramic Femoral Head SystemLZO · Special | 11/16/2004SE |
| K040225 | Oti Alumina Ceramic Femoral Head SystemKWZ · Traditional | 05/06/2004SE |
| K032729 | Z-Series Modular Total Hip SystemLPH · Traditional | 12/03/2003SE |
| K030608 | Oti Bone Cement PlugJDK · Traditional | 06/12/2003SESU |
| K022779 | Oti Unicondular Interpositional SpacerHSH · Traditional | 11/20/2002SE |
| K021822 | R120 Modular Total Hip SystemJDI · Traditional | 07/23/2002SE |
| K012762 | MJS Posterior Stabilized Knee SystemHRY · Traditional | 12/11/2001SE |
| K011774 | R120 Modular Total Hip SystemJDI · Traditional | 09/05/2001SE |
| K003316 | Oti Ceramic Femoral Head SystemLZO · Traditional | 01/19/2001SE |
| K003199 | Triad II Modular Total Hip SystemLPH · Traditional | 01/10/2001SE |
Questions and answers
When was Z - Series Modular Total Hip System Plasma Coated cleared by the FDA?
Z - Series Modular Total Hip System Plasma Coated (K040685) received a 510(k) decision of Substantially Equivalent on January 25, 2005, 315 days after the submission was received.
What is the product code of K040685?
The FDA product code is LWJ – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3360.