Who is the manufacturer of DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM?

Depuy, Inc. submitted the Traditional clearance for DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM (K964704).

What is the FDA product code for DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM?

LZO. It is classified under 21 CFR 888.3353 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM?

510(k) clearance (submission type: Traditional).

DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM

Q: What are the predicate devices for DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM?

DePuy Vision AML Hip Prosthesis; DePuy Quantum Hip Stem.

K964704 · Depuy, Inc. · LZO · Jan 24, 1997 · Orthopedic

Device Facts

Record ID	K964704
Device Name	DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM
Applicant	Depuy, Inc.
Product Code	LZO · Orthopedic
Decision Date	Jan 24, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3353
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The DePuy/Ace MMA Fracture Stem is indicated for cemented or press-fit cementless use as the femoral component in total hip arthroplasty (THA) for replacing the hip joints of patients whose hip joint has been damaged by fracture. The prosthesis may also be used for total hip arthroplasty for patients requiring total hip replacement for inflammatory or non-inflammatory degenerative joint disease or failure of a previous arthroplasty.

Device Story

Cast Co-Cr-Mo hip stem; triangular proximal body; rounded shoulder; straight distal stem; anterior/posterior grooves; 9-16.5mm diameter range. Used as femoral component in total hip arthroplasty (THA). Operates via cemented or press-fit cementless fixation. Features Articul-eze (12/14) taper for modular femoral head attachment. Used by orthopedic surgeons in clinical/OR settings. Replaces damaged hip joints; restores joint function; addresses degenerative disease or previous arthroplasty failure.

Clinical Evidence

Bench testing only; fatigue strength testing performed to demonstrate equivalence to predicate devices.

Technological Characteristics

Material: Cast Co-Cr-Mo alloy. Finish: Bead blasted. Geometry: Triangular proximal body, rounded shoulder, straight distal stem with anterior/posterior grooves. Fixation: Cemented or press-fit cementless. Interface: Articul-eze (12/14) taper for modular femoral heads. Sizes: 9mm to 16.5mm diameter.

Indications for Use

Indicated for patients requiring total hip arthroplasty due to hip joint fracture, inflammatory or non-inflammatory degenerative joint disease, or failure of a previous arthroplasty.

Regulatory Classification

Identification

A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

Predicate Devices

DePuy Vision AML Hip Prosthesis
DePuy Quantum Hip Stem

Reference Devices

DePuy Co-Cr-Mo or Zirconia Articul-eze taper modular femoral heads (K883460, K952088)

Related Devices

K030079 — VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS · Zimmer, Inc. · Feb 5, 2003
K191056 — Conformity stem, cemented · United Orthopedic Corporation · Jan 3, 2020
K141001 — ALPINE HIP STEM; ALPINE HA HIP STEM · Ortho Development · Jul 30, 2014
K120362 — METAFIX FEMORAL STEM FOR HEMI-ARTHROPLASTY · Corin USA · May 4, 2012
K992058 — BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM · Biomet, Inc. · Jul 1, 1999

Submission Summary (Full Text)

{0} K964704 JAN 24 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS **NAME OF FIRM:** DePuy Inc. 700 Orthopaedic Drive Warsaw, Indiana 46581-0988 **510(k) CONTACT:** Cheryl Hastings Manager, Clinical Affairs **TRADE NAME:** DePuy/Ace MMA Fracture Stem **COMMON NAME:** Cemented or Press-Fit Hip Stem **CLASSIFICATION:** 888.3353 Hip joint, metal/ceramic/polymer, semi-constrained, cemented or nonporous uncemented prosthesis. **DEVICE PRODUCT CODE:** 87 LZO **SUBSTANTIALLY EQUIVALENT DEVICES:** - DePuy Vision AML Hip Prosthesis - DePuy Quantum Hip Stem ## DEVICE DESCRIPTION AND INTENDED USE: The DePuy/Ace MMA Fracture Stem is a cast Co-Cr-Mo hip stem with a bead blasted finish. The stem has a triangular proximal body, a rounded shoulder, a straight distal stem, and anterior and posterior grooves that extend from the distal tip up approximately 60% of the length of the stem. Five sizes are available, ranging from 9 to 16.5mm in diameter. The DePuy/Ace MMA Fracture Stem has an Articul-eze (12/14) taper and is only to be used with the DePuy Co-Cr-Mo or Zirconia Articul-eze taper modular femoral heads (cleared in K883460 and K952088). The DePuy/Ace MMA Fracture Stem is indicated for cemented or press-fit cementless use as the femoral component in total hip arthroplasty (THA) for replacing the hip joints of patients whose hip joint has been damaged by fracture. The prosthesis may also be used for total hip arthroplasty for patients requiring total hip replacement for inflammatory or non-inflammatory degenerative joint disease or failure of a previous arthroplasty. ## BASIS OF SUBSTANTIAL EQUIVALENCE: The DePuy/Ace MMA Fracture Stem is substantially equivalent to the DePuy Vision Modified Medial Aspect (MMA) AML Prosthesis in that both stems are manufactured from cast Co-Cr-Mo and both have the same basic geometry. The only differences in the designs of these two stems are that the Fracture Stem has distal anterior and posterior {1} DePuy/Ace MMA Fracture Stem and the DePuy Vision Standard Triangle AML have approximately the same fatigue strength. The DePuy/Ace MMA Fracture Stem is intended for cemented or press-fit cementless fixation. The DePuy Vision AML is intended for fixation either with cement or by tissue ingrowth into the porous coating. The DePuy/Ace MMA Fracture Stem is also substantially equivalent to the DePuy Quantum Hip Stem in that both are manufactured from cast Co-Cr-Mo and both have similar designs. The design differences between the Fracture Stem and the Quantum Stem are that the Fracture Stem has distal anterior and posterior grooves, a rounded rather than square lateral shoulder, and a reduced taper diameter and collar size compared to the Quantum Stem. The smallest Fracture Stem has a diameter of 9.0mm whereas the smallest Quantum Stem has a diameter of 10.5mm. Both the Fracture Stem and the Quantum Stem are intended for cemented or press-fit cementless fixation.