(83 days)
Not Found
No
The document describes a mechanical shoulder implant system and its intended uses. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical integrity, packaging, and MR compatibility, not algorithmic performance.
Yes
This device is an implantable total or hemi- shoulder arthroplasty system intended to relieve pain and restore function in patients with various shoulder joint conditions, directly providing a therapeutic effect.
No
This device is an implant for shoulder arthroplasty, intended to relieve pain and restore function in patients with various shoulder conditions, not to diagnose them.
No
The device description clearly states it is comprised of families of products which are physical implants (Humeral Stems, Reverse System components, Fracture System components, etc.) intended for long-term implantation into the human shoulder joint. This is a hardware medical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that this device is a system of implants designed for surgical implantation into the human shoulder joint to replace damaged bone and restore function. This is an in vivo application (within the living body), not an in vitro application (outside the living body).
- Lack of IVD Characteristics: The text does not mention any testing of biological samples, analysis of biomarkers, or diagnostic purposes related to identifying diseases or conditions from bodily fluids or tissues.
Therefore, the Anatomical Shoulder Humeral Stems and Domelock System, along with the other components described, are surgical implants and not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
Hemi- or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System
The Anatomical Shoulder Humeral Stems and Domelock System are indicated for:
- Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis if bone stock is adequate.
- Avascular necrosis.
- Conditions consequent to earlier operations.
- Optional use in revision: in some medical conditions (e.g. early revision when adequate bone stock exits), the surgeon may opt to use primary implants in a revision procedure).
The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended for cemented use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Reverse Application of the Anatomical Shoulder System and ASHCOM Shoulder System
- The Anatomical Shoulder Reverse System and the ASHCOM Shoulder system are indicated forprimary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
- The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.
Fracture Application of the Anatomical Shoulder Fracture System
The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total, hemi- and fracture shoulder arthroplasty in treatment of the following: - Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment.
- Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment.
- Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment.
- Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus.
- Posttraumatic necrosis of the humeral head.
- Posttraumatic arthrosis after humeral head fracture.
The Humeral Fracture Stems are intended for either cemented or uncemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented are intended for cemented use only.
Anatomical Shoulder™ Combined System
Advanced destruction of the shoulder joint resulting from:
- Omarthrosis
- Rheumatoid arthritis
- Post-traumatic arthritis
- Avascular necrosis of the humeral head
- Cuff-tear arthropathy (Bigliani/Flatow Heads with heights of 27mm or greater)
- Conditions following earlier operations
The Anatomical Shoulder Combined System is intended for cemented or cementless use.
When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented use. - Anatomical Shoulder Standard Cemented Humeral Stem
- Anatomical Shoulder Long Stem
When used with the following humeral stem the Anatomical Shoulder Combined System is intended for cementless use: - Anatomical Shoulder Standard Uncemented Stem.
When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented or cementless use: - Anatomical Shoulder Fracture Stem.
- Anatomical Shoulder Fracture Long Stem.
When used with the following glenoids the Anatomical Shoulder Combined System is intended for cemented use: - Bigliani/Flatow Glenoid (pegged and keeled).
- Trabecular Metal™ Glenoid.
Product codes (comma separated list FDA assigned to the subject device)
PHX, HSD, KWS, KWT, PAO
Device Description
The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision (Reverse Shoulder Arthroplasty), total or hemi- shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
The proposed Anatomical Shoulder System is comprised of the following families of products:
- Anatomical Shoulder Humeral Stems (Cemented, Uncemented)
- Anatomical Shoulder Reverse System (Cups, PE-inlays, Glenoid Fixation, Screws, Glenospheres)
- Anatomical Shoulder Fracture System (Stems, Heads)
- Anatomical Shoulder Combined system (Bigliani / Flatow® Adaptors)
- Anaverse™ Anatomical Shoulder Pegged Glenoid
- Anatomical Shoulder Domelock® System (Heads, Dome Centric, T-Domes)
- Anatomical Shoulder ASHCOM® Shoulder System (ASHCOM Shoulder AC-Connector)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder joint, proximal humerus, glenoid articular surface of the scapula
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance and Conclusions:
Results of non-clinical performance testing and analyses demonstrate that the Anatomical Shoulder System is safe and effective and substantially equivalent to the predicate devices. Performance analyses included:
- MR compatibility evaluation on the Anatomical Shoulder™ System.
- No new MRI performance testing or simulations were completed for the Anatomical Shoulder™ System implant devices. The reports were only reviewed with the aim ensure that appropriate labelling of the Zimmer Shoulder implant systems be implemented upon harmonization of the MR verbiage across the Zimmer Biomet portfolio.
- Correction of instrument classification from Class I to Class II:
- Mechanical integrity and resistance testing was performed for instrument groups of mechanically loaded devices.
- Packaging configuration change:
- Packaging performance testing was performed to verify that packaging configuration maintains integrity of the sterile barrier system up to the point of use and provides adequate protection to the product through the hazards of sterilization, handling, distribution and storage according to ISO 11607-1:2006 and ISO 11607-2:2006. Packaging Configuration testing was conducted by representative worst-case products.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
ASHCOM™ Shoulder System, Anatomical Shoulder™ System, and Anatomical Shoulder™ Combined System, manufactured by Zimmer GmbH, K170711
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 29, 2020
Zimmer GmbH Dawn Balazs-Metz Regulatory Affairs Senior Specialist Sulzerallee 8 WINTERTHUR 8404 CH
Re: K193099
Trade/Device Name: Anatomical Shoulder System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, HSD, KWS, KWT, PAO Dated: November 4, 2019 Received: November 7, 2019
Dear Dawn Balazs-Metz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Michael Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K193099
Device Name Anatomical Shoulder™ System
Hemi- or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System The Anatomical Shoulder Humeral Stems and Domelock System are indicated for:
· Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or theumatoid arthritis if bone stock is adequate.
• Avascular necrosis.
· Conditions consequent to earlier operations.
· Optional use in revision: in some medical conditions (e.g. early revision when adequate bone stock exits), the surgeon may opt to use primary implants in a revision procedure).
The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intended use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Reverse Application of the Anatomical Shoulder System and ASHCOM Shoulder System
• The Anatomical Shoulder Reverse System and the ASHCOM Shoulder system are indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. • The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation.
Fracture Application of the Anatomical Shoulder Fracture System
The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid articular surface of the scapula during total, hemi- and fracture shoulder arthroplasty in treatment of the following: · Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment.
- · Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment.
- · Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment.
- · Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus.
- · Posttraumatic necrosis of the humeral head.
- Posttraumatic arthrosis after humeral head fracture.
The Humeral Fracture Stems are intended for either cemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented are intended for cemented use only.
Anatomical Shoulder Combined System
FORM FDA 3881 (7/17)
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Advanced destruction of the shoulder joint resulting from:
• Omarthrosis
• Rheumatoid arthritis
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- · Post-traumatic arthritis
- · Avascular necrosis of the humeral head
- · Cuff-tear arthropathy (Bigliani/Flatow Heads with heights of 27mm or greater)
- · Conditions following earlier operations
The Anatomical Shoulder Combined System is intended for cemented or cementless use.
When used with the following humeral stems the Anatomical System is intended for cemented use.
- Anatomical Shoulder Standard Cemented Humeral Stem
- · Anatomical Shoulder Long Stem
When used with the following humeral stem the Anatomical System is intended for cementless use: · Anatomical Shoulder Standard Uncemented Stem.
When used with the following humeral stems the Anatomical System is intended for cemented or cementless use:
· Anatomical Shoulder Fracture Stem.
-
· Anatomical Shoulder Fracture Long Stem.
When used with the following glenoids the Anatomical System is intended for cemented use: -
· Bigliani/Flatow Glenoid (pegged and keeled).
• Trabecular Metal™ Glenoid.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Image /page/4/Picture/3 description: The image contains the Zimmer Biomet logo. The logo consists of a blue circle with a stylized "Z" inside, followed by the words "ZIMMER BIOMET" in a sans-serif font. The color of the text is a light blue, matching the color of the "Z" symbol.
510(k) Summary
| Sponsor: | Zimmer GmbH
Sulzerallee 8, P.O. Box
8404 Winterthur, Switzerland |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dawn Balazs-Metz
Senior Specialist, Regulatory Affairs
Telephone: +41 58 854 81 37
Fax: +41 52 244 86 58 |
| Date: | November 04, 2019 |
| Trade Name: | Anatomical Shoulder™ System |
| Classification Product Code : | PHX - Shoulder Prosthesis, Reverse Configuration
HSD - Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWS - Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer
Cemented
KWT - Prosthesis, Shoulder, Non-Constrained, Metal/Polymer
Cemented
PAO - Prosthesis, Shoulder, Semi-constrained, Metal/Polymer +
Additive, Cemented |
| Device Classification Name: | Shoulder Prosthesis |
| Regulation Number / Description: | 21 CFR § 888.3660 - Shoulder joint metal/polymer semi-constrained
cemented prosthesis
21 CFR § 888.3690 - Shoulder joint humeral (hemi-shoulder) metallic
uncemented prosthesis
21 CFR § 888.3650 - Shoulder joint metal/polymer non-constrained
cemented prosthesis |
| Predicate Device: | ASHCOM™ Shoulder System, Anatomical Shoulder™ System, and
Anatomical Shoulder™ Combined System, manufactured by Zimmer
GmbH, K170711, cleared June 1, 2017. |
| Device Description: | Anatomical Shoulder™ System |
| | The Anatomical Shoulder System is intended for long-term
implantation into the human shoulder joint in primary or revision
(Reverse Shoulder Arthroplasty), total or hemi- shoulder arthroplasty.
The system is intended to relieve pain and restore function in patients
with adequate bone stock to support the prosthesis. |
| | The proposed Anatomical Shoulder System is comprised of the
following families of products: |
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| Anatomical Shoulder Humeral Stems (Cemented, Uncemented) | |
|---|---|
| Anatomical Shoulder Reverse System (Cups, PE-inlays, Glenoid Fixation, Screws, Glenospheres) | |
| Anatomical Shoulder Fracture System (Stems, Heads) | |
| Anatomical Shoulder Combined system (Bigliani / Flatow® Adaptors) | |
| Anaverse™ Anatomical Shoulder Pegged Glenoid | |
| Anatomical Shoulder Domelock® System (Heads, Dome Centric, T- Domes) | |
| Anatomical Shoulder ASHCOM® Shoulder System (ASHCOM Shoulder AC-Connector) | |
| Indications for use: | Hemi- or Total Arthroplasty Application of the Anatomical Shoulder Humeral Stems and Domelock System The Anatomical Shoulder Humeral Stems and Domelock System are indicated for: |
| • Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis if bone stock is adequate. | |
| • Avascular necrosis. | |
| • Conditions consequent to earlier operations. | |
| • Optional use in revision: in some medical conditions (e.g. early revision when adequate bone stock exits), the surgeon may opt to use primary implants in a revision procedure). | |
| The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented and the Biomet all- polyethylene Keeled Glenoid are intended for cemented use only. The Biomet Modular Hybrid Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement. | |
| Reverse Application of the Anatomical Shoulder System and ASHCOM Shoulder System | |
| • The Anatomical Shoulder Reverse System and the ASHCOM Shoulder system are indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. | |
| • The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. | |
| The Humeral Stems Cemented are intended for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used with the Anatomical Shoulder Glenoid Fixation, it is intended for uncemented use and requires two screws for fixation. Fracture Application of the Anatomical Shoulder Fracture System The Anatomical Shoulder Fracture System is intended for use in prosthetic replacement of the proximal humerus and the glenoid |
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Image /page/6/Picture/2 description: The image contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color.
articular surface of the scapula during total, hemi- and fracture shoulder arthroplasty in treatment of the following:
- · Complex 3- and 4-part fractures of the proximal humerus with subluxation of the head fragment.
- · Complex 3- and 4-part fractures of the proximal humerus with loosening of the spongiosa in the head fragment.
- · Complex 3- and 4-part fractures of the proximal humerus with additional cross split of the head fragment.
- · Fracture instability after osteosynthesis of 3- and 4-part fracture fragments of the proximal humerus.
- · Posttraumatic necrosis of the humeral head.
- · Posttraumatic arthrosis after humeral head fracture.
The Humeral Fracture Stems are intended for either cemented or uncemented use. When used in a total shoulder application, the Anaverse Anatomical Shoulder Pegged Glenoids Cemented are intended for cemented use only.
Anatomical Shoulder™ Combined System
Advanced destruction of the shoulder joint resulting from:
- · Omarthrosis
- · Rheumatoid arthritis
- Post-traumatic arthritis
- · Avascular necrosis of the humeral head
- · Cuff-tear arthropathy (Bigliani/Flatow Heads with heights of 27mm or greater)
- · Conditions following earlier operations
The Anatomical Shoulder Combined System is intended for cemented or cementless use.
When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented use.
- · Anatomical Shoulder Standard Cemented Humeral Stem
- · Anatomical Shoulder Long Stem
When used with the following humeral stem the Anatomical Shoulder Combined System is intended for cementless use:
-
· Anatomical Shoulder Standard Uncemented Stem.
When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented or cementless use: -
· Anatomical Shoulder Fracture Stem.
-
· Anatomical Shoulder Fracture Long Stem.
When used with the following glenoids the Anatomical Shoulder Combined System is intended for cemented use:
- · Bigliani/Flatow Glenoid (pegged and keeled).
- · Trabecular Metal™ Glenoid.
Comparison to Predicate Device:
The Anatomical Shoulder System is being merged. Through merging of the IFU redundant indications have been removed and three
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| existing indications have been reworded for more clarity surrounding revision cases. The removal and clarification of the indications for the subject device limits the use of the devices within the currently cleared indications. A clarification to the previously cleared MR verbiage for the proposed device harmonizes the information provided to the user across the Zimmer Biomet shoulder portfolio. The clarification to the MR verbiage does not change compatibility/ final scanning recommendations provided to the user. | ||
|---|---|---|
| Modification of the packaging configuration for the subject implant devices is proposed. The proposed changes do not alter the fundamental scientific technology shared by both the subject devices and predicate devices. | ||
| Zimmer GmbH is furthermore seeking clearance for certain system-specific Class II instruments - these instruments that have previously considered Class I exempt and correction of classification to Class II is proposed within present submission. | ||
| Performance Data (Nonclinical and/or Clinical): | Non-Clinical Performance and Conclusions: | |
| Results of non-clinical performance testing and analyses demonstrate that the Anatomical Shoulder System is safe and effective and substantially equivalent to the predicate devices. Performance analyses included: | ||
| MR compatibility evaluation on the Anatomical Shoulder™ System. | ||
| No new MRI performance testing or simulations were completed for the Anatomical Shoulder™ System implant devices. The reports were only reviewed with the aim ensure that appropriate labelling of the Zimmer Shoulder implant systems be implemented upon harmonization of the MR verbiage across the Zimmer Biomet portfolio. | ||
| Correction of instrument classification from Class I to Class II: | ||
| Mechanical integrity and resistance testing was performed for instrument groups of mechanically loaded devices. | ||
| Packaging configuration change: | ||
| Packaging performance testing was performed to verify that packaging configuration maintains integrity of the sterile barrier system up to the point of use and provides adequate protection to the product through the hazards of sterilization, handling, distribution and storage according to ISO 11607-1:2006 and ISO 11607-2:2006. Packaging Configuration testing was conducted by representative worst-case products. | ||
| Clinical Performance and Conclusions: | ||
| Clinical data and conclusions were not needed for this device. | ||
| Conclusion: | The subject devices have the same intended use and similar indications for use as the predicate devices. The subject devices use the same operating principle, incorporate the same basic design and labeling and are manufactured and sterilized using the same materials and processes as the predicate devices. |
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devices are identical to the predicate devices, and the performance data and analyses demonstrate that:
- . any differences do not raise new questions of safety and effectiveness as established with performance testing; and
- . the subject devices are at least as safe and effective as the legally marketed predicate devices.