Ring UPM Total Hip Replacement

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K864515 ↗

FDA Product Code

KWA

FDA applicant

Downs Surgical , Ltd.

Device Class

Class III

Regulation

21 CFR Part 888.3330

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Valvotomy Knife

  Class I

  FDA 510(k) K843371 Active Cleared 25 Oct 1984

• Wellington Hospital Pattern Self-Retain

  Class I

  FDA 510(k) K843388 Active Cleared 1 Oct 1984

• Wilcox Rod & Plate Bender

  Not classified

  FDA 510(k) K840547 Active Cleared 31 Oct 1984

• Islam Sternal Puncture Needle, Cat # Af-594-00-V

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• Sano Clip Appliers & Removers

  Class II

  FDA 510(k) K881912 Active Cleared 6 Jun 1988

• Downs Surgical Titanium Autocompression Plates

  Not classified

  FDA 510(k) K862945 Active Cleared 20 Aug 1986

See all devices from Downs Surgical, Ltd. →

• What types of hip conditions is the Ring UPM Total Hip Replacement designed to address, and how does its semi-constrained design benefit patients?

  The Ring UPM Total Hip Replacement is specifically designed to replace a damaged or diseased hip joint, offering stability and mobility through articulation with a femoral component. Its semi-constrained metal acetabular shell is intended for long-term integration with the patient’s pelvis, reducing dislocation risk while allowing natural movement. This design is particularly suited for patients requiring a balance of stability and flexibility, such as those with severe osteoarthritis or other degenerative joint diseases.

• Is the Ring UPM Total Hip Replacement reusable or single-use, and what storage guidelines should be followed to maintain sterility?

  The Ring UPM Total Hip Replacement is supplied as a sterile, single-use implant. To preserve sterility, it must be handled and stored according to standard sterile surgical protocols. This includes keeping the device in its original packaging until immediately before use and ensuring the storage environment is clean, dry, and protected from contamination.

• What model references are available for the Ring UPM Total Hip Replacement, and how do I confirm compatibility with my patient’s anatomy?

  The Ring UPM Total Hip Replacement comes in multiple model references, including K864515 and others listed under the registration numbers (e.g., 8043792, 3020282716, etc.). Compatibility depends on factors like pelvic bone structure and joint damage. Consulting with an orthopedic surgeon and reviewing pre-operative imaging is essential to select the appropriate model for your patient’s specific anatomy and clinical needs.

• How was the Ring UPM Total Hip Replacement evaluated for safety and effectiveness, and what role did the Orthopedic Advisory Committee play in its approval?

  The Ring UPM Total Hip Replacement was cleared via a Traditional 510(k) pathway, determined to be Substantially Equivalent to a legally marketed predicate device. The Orthopedic (OR) Advisory Committee reviewed the submission in 1987, providing expert input on its design, safety, and clinical performance before FDA clearance. This process ensures the device meets established standards for hip prostheses.

• What regulatory category does the Ring UPM Total Hip Replacement fall under, and how does this classification impact its use in clinical settings?

  The Ring UPM Total Hip Replacement is classified under FDA regulation 888.3330 as a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) and is categorized as a Class III device. This classification reflects its role in replacing critical joint function and requires rigorous pre-market evaluation to ensure safety and efficacy. Clinically, this means it must be implanted by trained orthopedic surgeons in sterile conditions, adhering to established surgical protocols.