AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert

• K Number: K172351
• Device Name: AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert
• Manufacturer: Encore Medical, L.P.
• Date Cleared: 2017-10-30 ( 88 days)
• Product Code: KWS , HSD , PHX
• Regulation Number: 888.3660
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K141990 , K100741 , K111061 , K111735 , K141006 , K052906

Intended Use

Indications for AltiVate™ Stem:

Anatomic Total Shoulder Indications:
The AltiVate™ Shoulder Prosthesis Stem is indicated as an Anatomic shoulder joint replacement for patients suffering from pain and dysfunction due to:

• Noninflammatory degenerative joint disease including osteoarthritis;
• Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis;
• Post-traumatic arthritis of the glenohumeral joint;
• Avascular necrosis of the humeral head with and without involvement of the glenoid;
• Correction of functional deformity ●

The all-poly glenoid is intended for cemented use

Hemi Shoulder Indications:
The AltiVate™ Shoulder Prosthesis Stem is indicated as a hemi shoulder joint replacement for patients suffering from pain and dysfunction due to:

• Noninflammatory degenerative joint disease including osteoarthritis; ●
• Inflammatory arthritis of the glenohumeral joint including rheumatoid arthritis; ●
• Post-traumatic arthritis of the glenohumeral joint;
• Avascular necrosis of the humeral head with and without involvement of the glenoid;
• Correction of functional deformity;
• Rotator cuff tear arthropathy;
• Humeral fracture.
• Failed previous shoulder surgery

Reverse Total Shoulder Indications:
The AltiVate™ Shoulder Prosthesis Stem is as a reverse shoulder replacement for patients with a functional deltoid muscle and a grossly deficient rotator cuff joint suffering from pain and dysfunction due to:

• Severe arthropathy with a grossly deficient rotator cuff;
• . Previously failed joint replacement with a grossly deficient rotator cuff;
• . Fracture of glenohumeral joint from trauma or pathologic conditions of the shoulder including humeral head fracture, displaced 3- or 4-part fractures of proximal humerus, or reconstruction after tumor resection;
• . Bone defect in proximal humerus;
• . Non-inflammatory degenerative disease including osteoarthritis and avascular necrosis of the natural humeral head and/or glenoid;
• Inflammatory arthritis including rheumatoid arthritis;
• Correction of functional deformity.

The glenoid baseplate is intended for cementless application with addition of screws for fixation. This device may also be indicated in the salvage of previously failed surgical attempts for anatomic and hemi procedures

All humeral stems are intended for cemented or cementless use.

Device Description

The AltiVate™ Reverse Small Shell Shoulder is a line extension to the AltiVate Reverse System. It consists of four primary components: humeral stem, socket insert, spacer and hemi-adaptor. Device specific instrumentation will also be used. Components are offered for either primary or revision surgery applications, in a hemi or total shoulder application.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding a shoulder joint prosthesis (AltiVate Reverse Humeral Stem, etc.).

It primarily discusses:

• The FDA's substantial equivalence determination for the device.
• Regulatory information and requirements for the manufacturer.
• Indications for Use of the device (Anatomic Total Shoulder, Hemi Shoulder, Reverse Total Shoulder).
• Comparison to predicate devices (previously marketed and cleared devices).
• Non-clinical testing (mechanical testing, endotoxin assessment) that determined substantial equivalence.
• A statement that clinical testing was not required.

Therefore, I cannot provide details on:

1. A table of acceptance criteria and reported device performance (as clinical performance criteria are not defined for this 510(k)).
2. Sample size and data provenance for a test set (as no clinical test set was used).
3. Number and qualifications of experts for ground truth (as no clinical ground truth was established by experts).
4. Adjudication method (not applicable).
5. MRMC comparative effectiveness study (not applicable).
6. Standalone algorithm performance (not applicable, as this is a physical medical device, not an AI algorithm).
7. Type of ground truth (not applicable).
8. Sample size for the training set (not applicable, as no training set for an algorithm was used).
9. How ground truth for the training set was established (not applicable).

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.”