(53 days)
Not Found
No
The document describes a modular shoulder prosthesis and its intended uses, focusing on mechanical components and surgical procedures. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is an artificial shoulder joint system intended to relieve pain and restore function, which directly aligns with the definition of a therapeutic device.
No
This device is a shoulder prosthesis, designed for arthroplasty (surgical replacement of a joint), and is not used for diagnosing medical conditions.
No
The device description clearly describes physical implants (humeral stems, glenoid components) intended for surgical implantation, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description and Intended Use: The description and intended use clearly state that this device is a shoulder prosthesis designed for surgical implantation into the human shoulder joint. It is used to replace damaged joint surfaces and restore function.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's condition through testing of bodily fluids or tissues.
The device is a surgical implant used for treatment, not for in vitro diagnostic testing.
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.
- · Avascular necrosis.
- · Conditions consequent to earlier operations.
- · Omarthrosis.
- · Rheumatoid arthritis.
- · Revision of shoulder prosthesis.
The Humeral Stems Cemented are intented for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intented 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
· The Anatomical Shoulder Inverse/Reverse System is 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 glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasts 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 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 Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only.
Prescription Use (Part 21 CFR 801 Subpart D)
Product codes (comma separated list FDA assigned to the subject device)
KWS, KWT, HSD, PHX
Device Description
The Anatomical Shoulder System is a modular shoulder prosthesis designed to be used in primary or revision, total or hemi shoulder arthroplasty.
Anatomical Shoulder Humeral Stems are available as either cemented or uncemented designs. Cemented stems are available in longer designs to support revision cases. The Anatomical Shoulder Fracture Stem is available as a slim and standard version, with longer stems available for revision surgery. They may be used with or without bone cement where appropriate fixation using cement or via a press-fit is achieved using the correct choice of rasp size. All Humeral Stems possess a female oval taper geometry, which is the basis for all modularity with compatible mating components. The stems can be combined with the Anatomical Shoulder Domelock Head or the Anatomical Shoulder Ball-taper Humeral Head. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component of the Anatomical Shoulder System for total arthroplasty. Alternatively, the Legacy Biomet Bio-Modular Keeled all-polyethylene Glenoid or Modular Hybrid Glenoids are proposed as compatible glenoid components.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder joint, proximal humerus, 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)
The results of non-clinical performance testing and analyses demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance analyses included:
- Range of Motion Analysis (ASTM F1378-12)
- Radial Mismatch Analysis
Clinical Performance and Conclusions: Clinical data and conclusions were not needed to demonstrate substantial equivalence.
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.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, representing the human element of the department's work.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2016
Zimmer Gmbh Ms. Annemie Rehor Kausch Senior Specialist Regulatory Affairs Sulzerallee 8 8404 Winterthur Switzerland
Re: K160085
Trade/Device Name: Anatomical Shoulder™ System, Anatomical Shoulder Domelock® System, Anatomical Shoulder™ Fracture System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT, HSD, PHX Dated: January 8, 2016 Received: January 15, 2016
Dear Ms. Rehor Kausch:
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. 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 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
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160085
Device Name
Anatomical Shoulder™ System Anatomical Shoulder™ Domelock® Anatomical Shoulder™ Fracture System
Indications for Use (Describe)
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.
- · Avascular necrosis.
- · Conditions consequent to earlier operations.
- · Omarthrosis.
- · Rheumatoid arthritis.
- · Revision of shoulder prosthesis.
The Humeral Stems Cemented are intented for cemented use and the Humeral Stems Uncemented are intended for uncemented use. When used in a total shoulder application, the Anatomical Shoulder Pegged and Keeled Glenoids Cemented and the Biomet all-polyethylene Keeled Glenoid are intented 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
· The Anatomical Shoulder Inverse/Reverse System is 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 glenoid articular surface of the scapula during total-, hemi and fracture shoulder arthroplasts 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 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 Anatomical Shoulder Pegged and Keeled Glenoids Cemented are intended for cemented use only. 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)
3
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4
Image /page/4/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a stylized blue letter "Z" inside of a blue circle. Below the circle is the word "zimmer" in a lowercase, sans-serif font, also in blue.
510(k) Summary
| Sponsor: | Zimmer GmbH
Sulzerallee 8, P.O. Box
8404 Winterthur, Switzerland |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Annemie Rehor Kausch
Senior Specialist, Regulatory Affairs
Telephone: +41 58 854 82 61
Fax: + 41 52 244 86 58 |
| Date: | March, 1st 2016 |
| Trade Name: | Anatomical Shoulder™ System
Anatomical Shoulder ™ Domelock®
Anatomical Shoulder ™ Fracture System |
| Classification Product Code / | HSD - Prosthesis, Shoulder, Hemi-, Humeral,
Metallic Uncemented
KWS - Prosthesis, Shoulder, Semi-Constrained,
Metal/Polymer Cemented
KWT - Prosthesis, Shoulder, Non-Constrained,
Metal/Polymer Cemented
PHX - Shoulder Prosthesis, Reverse Configuration |
| Device Classification Name: | Shoulder Prosthesis |
| Regulation Number / Description: | 21 CFR § 888.3690 – Shoulder joint humeral
(hemishoulder) metallic uncemented prosthesis
21 CFR § 888.3660 – Shoulder joint metal/polymer
semi-constrained cemented prosthesis
21 CFR § 888.3650 – Shoulder joint metal/polymer
non-constrained cemented prosthesis |
| Predicate Device: | Anatomical Shoulder System / Anatomical Shoulder
Domelock / Anatomical Shoulder Fracture System,
manufactured by Zimmer GmbH, K142403, cleared
November 24, 2014 |
5
Anatomical Shoulder with Removable Head, manufactured by Zimmer GmbH, K030259, cleared April 24, 2003
Anatomical Shoulder Fracture Stem, K062029, cleared July 17, 2006.
The Anatomical Shoulder System is a modular shoulder prosthesis designed to be used in primary or revision, total or hemi shoulder arthroplasty.
Anatomical Shoulder Humeral Stems are available as either cemented or uncemented designs. Cemented stems are available in longer designs to support revision cases. The Anatomical Shoulder Fracture Stem is available as a slim and standard version, with longer stems available for revision surgery. They may be used with or without bone cement where appropriate fixation using cement or via a press-fit is achieved using the correct choice of rasp size. All Humeral Stems possess a female oval taper geometry, which is the basis for all modularity with compatible mating components. The stems can be combined with the Anatomical Shoulder Domelock Head or the Anatomical Shoulder Ball-taper Humeral Head. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component of the Anatomical Shoulder System for total arthroplasty. Alternatively, the Legacy Biomet Bio-Modular Keeled all-polyethylene Glenoid or Modular Hybrid Glenoids are proposed as compatible glenoid components.
The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, 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.
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
Intended Use:
Indications for Use:
Device Description:
6
- · Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis.
- Avascular necrosis.
- · Conditions consequent to earlier operations.
- Omarthrosis.
- · Rheumatoid arthritis.
- · Revision of shoulder prosthesis.
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 Anatomical Shoulder Pegged and Keeled 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
· The Anatomical Shoulder Inverse/Reverse System is 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
7
| | 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 Anatomical Shoulder
Pegged and Keeled Glenoids Cemented are intended
for cemented use only. |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Comparison to Predicate Device: | The devices are not modified as compared to their
predicates. Instead, the compatibility of the
Anatomical Shoulder Humeral Heads is extended to
allow articulation against the legally marketed Bio-
Modular Keeled all-polyethylene Glenoid and the
Modular Hybrid Glenoid. The indications for
use/intended use are unchanged. The articulating
materials remain the same with the new compatibility
and therefore the fundamental technology is
unchanged. |
| Performance Data (Nonclinical
and/or Clinical): | The results of non-clinical performance testing and
analyses demonstrate that the devices are safe and
effective and substantially equivalent to the predicate
devices. Performance analyses included:
- Range of Motion Analysis (ASTM F1378-12)
- Radial Mismatch Analysis |
| | Clinical Performance and Conclusions: Clinical data
and conclusions were not needed to demonstrate
substantial equivalence. |