HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL— 510(k) K990666

Clearance details

Applicant

Smith & Nephew, Inc.

Product code

Code MEH

Device class

Class 2

Regulation

21 CFR 888.3353

Advisory panel

Orthopedic

Date received

1999-03-02

Decision date

1999-08-06

Decision

Substantially Equivalent

Clearance type

Abbreviated

Location

Memphis, TN, US

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Injury

2,021

Total

2,021

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-2297-2016 — SPHERICAL HEAD REFLECTION(R) 6.5 MM CANCELLOUS SCREW, REF 71332525, QTY: (1), STERILE R, smith&nephew Total hip components are indicated for individuals undergoing primary or revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant; congenital dysplasia; old, remote osteomyelitis with an extended drainage-free period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.Class II·Terminated·Smith & Nephew, Inc.·20160706

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K990666.