The Implex Hedrocel Acetabular Augment, Xx-Yyy-Zzzz
FDA 510(k) K001471 · Implex Corp.
510(k) numberK001471
Submission
- Device name
- The Implex Hedrocel Acetabular Augment, Xx-Yyy-Zzzz
- Applicant
- Implex Corp.
Allendale, NJ, US - Received
- May 11, 2000
- Decision date
- August 7, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K051978 | Trabecular Metal Vertebral Body ReplacementMQP · Special | 09/23/2005SE |
| K051196 | Trabecular Metal Vertebral Body Replacement, Model 06-165-011X1 and 06-166-051X1MQP · Special | 06/17/2005SE |
| K040487 | Trabecular Metal Knee System AugmentsMBH · Traditional | 12/21/2004SE |
| K040630 | Trabecular Metal Femoral Cone Augments, Model 03-125-ZZZZJWH · Traditional | 09/30/2004SE |
| K040756 | The Trabecular Metal Reconstruction System, Model 10-340-XXXXXFTM · Special | 07/14/2004SE |
| K031962 | Nexgen Trabecular Metal Tibial Cone AugmentsJWH · Traditional | 01/08/2004SE |
| K033384 | The Hedrocel Trabecular Metal Reconstruction System, Model 06-165-ZZZZJDK · Special | 11/19/2003SE |
| K032527 | Hedrocel Vertebral Body ReplacementMQP · Special | 10/31/2003SE |
| K032344 | The Hedrocel Trabecular Metal Reconstruction System Model 10-330EZX · Special | 10/02/2003SE |
| K031449 | Modification to the Trabecular Metal Glenoid - Bigliani/Flatow the Complete Shoulder…KWS · Traditional | 09/23/2003SE |
Questions and answers
When was The Implex Hedrocel Acetabular Augment, Xx-Yyy-Zzzz cleared by the FDA?
The Implex Hedrocel Acetabular Augment, Xx-Yyy-Zzzz (K001471) received a 510(k) decision of Substantially Equivalent on August 7, 2000, 88 days after the submission was received.
What is the product code of K001471?
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.