I.T.S. PELVIC RECONSTRUCTION SYSTEM— 510(k) K063166
Substantially EquivalentI.T.S. Implantat-Technologie-Systeme GmbH
FDA 510(k) clearance K063166 for I.T.S. PELVIC RECONSTRUCTION SYSTEM, Substantially Equivalent on 2006-12-22. Applicant: I.T.S. Implantat-Technologie-Systeme GmbH. Device class: 2.
Clearance details
- Applicant
- I.T.S. Implantat-Technologie-Systeme GmbH
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Prior Lake, MN, US
Recent devices under product code HRS
view allMore clearances from I.T.S. Implantat-Technologie-Systeme GmbH
view allAdverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K063166
K-number listed on FDA's recall record- Z-1600-2026 — Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1. Fixation Screw; Article Number: 70312. 2. Spike short; Article Number: 70314.
- Z-1718-2019 — Rim Plate, 10-Hole, Left, PRS RX System. Titanium, implantable - Product Usage: The implant temporarily stabilizes bone segments until bony consolidation has taken place. After this, the implant has no more use and can be removed.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063166.
Data sourced from openFDA. This site is unofficial and independent of the FDA.