Prosthesis, Hip, Hemi-, Femoral, Metal Ball
The Metal Ball Femoral Hemi-Hip Prosthesis (product code LZY) is an orthopedic implant used to replace only the femoral head (ball) of the hip joint, used in cases of femoral neck fracture or avascular necrosis where the acetabular socket does not require replacement. Regulated under 21 CFR 888.3360 and classified as a Class 2 device, it requires a 510(k) premarket notification and is flagged as an implant. The device falls under the Orthopedic specialty. It is not life-sustaining.
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Basic Information
- Product Code
- LZY
- Device Class
- FDA class 2
- Regulation Number
- 888.3360
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K231448 | TANDEM Hip System | Jul 19, 2023 | Substantially Equivalent | Smith & Nephew, Inc. |
| K111145 | ENDO HEAD | Aug 16, 2011 | Substantially Equivalent | Medacta International |
| K974442 | PRE-POWDERED NITRILE EXAMINATION GLOVES | Jan 05, 1998 | Substantially Equivalent | P.T. Latexindo Tobaperkasa |
| K915528 | BHR BIPOLAR FEMORAL HEAD COMPONENT | Jun 29, 1993 | Substantially Equivalent | Implantology Corp. |
| K915548 | IONGUARD TITANIUM MODULAR HEADS | Mar 10, 1992 | Substantially Equivalent | Biomet, Inc. |
| K903084 | MODULAR CATHCART FRACTURE SYSTEM | Oct 03, 1990 | Substantially Equivalent | Depuy, Inc. |
| K896580 | UNI-POLAR HEAD | Feb 15, 1990 | Substantially Equivalent | Richards Medical Co., Inc. |
| K892059 | FEMORAL HEADS/MODULAR & FIXED W/ TITAN NITRIDE SUR | Jul 19, 1989 | Substantially Equivalent | Protek, Inc. |
FEI Numbers
This FDA classification entry is associated with 53 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 53 registration numbers. Click on an entry to view related FDA registrations.