I.T.S. Pelvic Reconstruction System
FDA 510(k) K063166 · I.T.S. Implantat-Technologie-Systeme GmbH
510(k) numberK063166
Submission
- Device name
- I.T.S. Pelvic Reconstruction System
- Applicant
- I.T.S. Implantat-Technologie-Systeme GmbH
Prior Lake, MN, US - Received
- October 18, 2006
- Decision date
- December 22, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HRS – Plate, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3030
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code HRS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261647 | Tempo Plating System; Ultra Compression Screw SystemHRS · Traditional | Pace Surgical | 09/03/2026SE |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See…HRS · Traditional | Ortler Global Tibbi Gerecler Anonim Sirketi | 08/28/2026SE |
| K262537 | Versalock Sterile Plating SystemHRS · Special | GM Dos Reis Industria e Comercio Ltda. | 08/19/2026SE |
| K260277 | Mikron Trauma Bone Plate& Screw SystemHRS · Traditional | Mikron Makina San. ve Tic. Ltd. Sti. | 08/13/2026SE |
| K261511 | Xpert AnkleHRS · Traditional | Newclip Technics | 07/28/2026SE |
| K261406 | Versalock Proximal Tibial Plating SystemHRS · Traditional | GM Dos Reis Industria e Comercio Ltda. | 07/21/2026SE |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion…HRS · Special | TriMed, Inc. | 07/16/2026SE |
| K261191 | Alians Elbow SHRS · Traditional | Newclip Technics | 07/08/2026SE |
| K261054 | RibPlate SystemHRS · Traditional | Stryker Leibinger GmbH & Co KG | 07/01/2026SE |
| K261351 | SALGINA 2.5mm Distal Radius SystemHRS · Traditional | Bonebridge AG | 06/26/2026SE |
More from Bonebridge AG
| 510(k) | Device | Decision |
|---|---|---|
| K093868 | I.T.S. LRS Locking Reconstruction SystemHRS · Traditional | 08/05/2010SE |
| K080706 | Connexx Locking Tibia NailJDS · Traditional | 06/09/2008SE |
| K080184 | Distal Humeral Plates with Angular StabilityHRS · Traditional | 03/26/2008SE |
| K063672 | Fibula Plate Prolock with Angular StabilityHRS · Traditional | 02/02/2007SE |
| K060156 | Straight Plate with Angular Stability & Screw SystemHRS · Traditional | 03/20/2006SE |
| K052368 | Olecranonplate with Angular StabilityHRS · Traditional | 10/17/2005SE |
| K051642 | Fr.O.H. Calcaneus Repair SystemNDF · Traditional | 08/22/2005SE |
| K052011 | Pilonplate with Angular StabilityHRS · Traditional | 08/10/2005SE |
| K051412 | Humeral Head Plate with Angular StabilityHRS · Traditional | 07/11/2005SE |
| K050852 | Claviculaplate with Angular Stablity Bone Plate SystemHRS · Traditional | 06/22/2005SE |
Questions and answers
When was I.T.S. Pelvic Reconstruction System cleared by the FDA?
I.T.S. Pelvic Reconstruction System (K063166) received a 510(k) decision of Substantially Equivalent on December 22, 2006, 65 days after the submission was received.
What is the product code of K063166?
The FDA product code is HRS – Plate, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3030.