ORTHO DEVELOPMENT BALANCED KNEE SYSTEM— 510(k) K994370
Substantially EquivalentOrtho Development Corp.
FDA 510(k) clearance K994370 for ORTHO DEVELOPMENT BALANCED KNEE SYSTEM, Substantially Equivalent on 2000-03-24. Applicant: Ortho Development Corp.. Device class: 2.
Clearance details
- Applicant
- Ortho Development Corp.
- Product code
- Code JWH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3560
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Draper, UT, US
Recent devices under product code JWH
view allMore clearances from Ortho Development Corp.
view allAdverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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 K994370
K-number listed on FDA's recall record- Z-1903-2020 — Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
- Z-1904-2020 — Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
- Z-2254-2014 — Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component
- Z-2255-2014 — PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component
- Z-1610-2014 — PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K994370.
Data sourced from openFDA. This site is unofficial and independent of the FDA.