BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS

• K Number: K992899
• Device Name: BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS
• Manufacturer: BIOMET, INC.
• Date Cleared: 1999-10-21 ( 52 days)
• Product Code: KWS
• Regulation Number: 888.3660
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: N/A

Intended Use

The Bio-Modular Shoulder System is intended for partial or total shoulder ioint arthroplasty.
Indications for use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Revision where other devices or treatments have failed
4. Correction of functional deformity
5. Treatment of acute fracture of the humeral head unmanageable using other treatment methods.
6. Cuff tear arthropathy

Device Description

Offset Humeral Heads are a modification of standard modular heads. Rather than a modular head with a centered stem providing the same amount of bearing surface circumferentially from the stem, the stem is place 5 degrees off the center point of the head providing a greater amount of bearing surface. This gives the surgeon the ability to more closely reconstruct the natural anatomy of the patient's shoulder and potentially reduce the risk of dislocation. In order to replicate trial orientation of the Offset Humeral Head, an alignment pin is provided which fits into a hole in the humeral stem and then may be aligned with on of 8 holes on the under surface of the head. The Bio-Modular Offset Humeral Heads are manufactured from cobalt alloy (Co-Cr-Mo) conforming to ASTM F-1537.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the Bio-Modular Shoulder Offset Humeral Heads. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and performance metrics for the new device itself.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. Specifically:

• No table of acceptance criteria and reported device performance is present. The document focuses on comparing the new device to existing, already-approved devices, rather than establishing and meeting new performance benchmarks.
• No sample size for a test set, data provenance, number of experts for ground truth, or adjudication method are mentioned because a clinical study of this nature was not conducted or reported for the 510(k) submission.
• No multi-reader multi-case (MRMC) comparative effectiveness study is discussed.
• No standalone algorithm performance is applicable as this is a physical implant, not an AI/software device.
• No specific type of ground truth used for a device performance study is mentioned.
• No sample size for a training set or how ground truth for a training set was established are provided, as this is not an AI/software device and thus does not involve training data in the AI sense.

The document primarily focuses on:

1. Device Description: Explaining the features and construction of the Bio-Modular Shoulder Offset Humeral Heads.
2. Intended Use and Indications for Use: Delineating the medical conditions for which the device is intended.
3. Potential Risks: Listing known risks associated with joint replacement devices in general.
4. Substantial Equivalence: Identifying predicate devices (Bio-Modular Shoulder System, Aequalis Shoulder Prosthesis, Global Dialable Eccentric Head) to which the new device is compared to argue for its safety and effectiveness. The FDA's letter confirms this determination of substantial equivalence.

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”