ECHO BI-METRIC PRESS-FIT STEMS— 510(k) K070274
Substantially EquivalentBiomet Manufacturing Corp
FDA 510(k) clearance K070274 for ECHO BI-METRIC PRESS-FIT STEMS, Substantially Equivalent on 2007-04-03. Applicant: Biomet Manufacturing Corp. Device class: 3.
Clearance details
- Applicant
- Biomet Manufacturing Corp
- Product code
- Code KWA
- Device class
- Class 3
- Regulation
- 21 CFR 888.3330
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Warsaw, IN, US
Recent devices under product code KWA
view allMore clearances from Biomet Manufacturing Corp
view allAdverse events under product code KWA
product code KWA- Death
- 38
- Injury
- 10,439
- Malfunction
- 1,862
- Total
- 12,339
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 K070274
K-number listed on FDA's recall record- Z-2821-2018 — ECHO Bi-Metric Hip System, Reduced Proximal Profile, Standard 135o neck, item number 192414. orthopedic hip prosthesis femoral stem
- Z-0300-2018 — ECHO POR FMRL NC 9X125, model # 192009
- Z-0442-2013 — Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K070274.
Data sourced from openFDA. This site is unofficial and independent of the FDA.