Anatomical Shoulder Domelock Dome centric
Device Facts
| Record ID | K161620 |
|---|---|
| Device Name | Anatomical Shoulder Domelock Dome centric |
| Applicant | Zimmer GmbH |
| Product Code | HSD · Orthopedic |
| Decision Date | Nov 1, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.3690 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Anatomical Shoulder Domelock 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.
Device Story
Modular shoulder prosthesis system for primary or revision total/hemi arthroplasty. Components include humeral stems (cemented/uncemented), humeral heads, and Domelock Dome centric mechanism (expansion ball and pin) for setting head orientation. Humeral stems feature female oval taper geometry for modularity. Assembled components used for hemiarthroplasty or combined with glenoid components (pegged, keeled, or hybrid) for total arthroplasty. Used in clinical/surgical settings by orthopedic surgeons. Provides mechanical replacement of shoulder joint surfaces to relieve pain and restore function. Benefits include improved joint stability and mobility in patients with adequate bone stock.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via non-clinical performance testing, including functional relationship analysis and Finite Element Analysis (FEA) for fatigue strength.
Technological Characteristics
Modular shoulder prosthesis. Materials unchanged from predicate. Components include humeral stems, humeral heads, and Domelock mechanism (expansion ball/pin). Features female oval taper geometry. Designed for cemented or uncemented use depending on component. No software or electronic components.
Indications for Use
Indicated for patients requiring primary, revision, or fracture total/hemi shoulder arthroplasty due to degenerative, posttraumatic, or rheumatoid arthritis, avascular necrosis, omarthrosis, or conditions from prior operations. Reverse application indicated for pain/disability from gross rotator cuff deficiency with functional deltoid. Fracture application indicated for complex 3- and 4-part proximal humerus fractures, posttraumatic necrosis, or posttraumatic arthrosis. Contraindicated if joint anatomy is unsuitable or deltoid muscle is non-functional.
Regulatory Classification
Identification
A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.
Predicate Devices
- Anatomical Shoulder Domelock Dome centric (part of Anatomical Shoulder System) (K142403)
- Anatomical Shoulder Fracture System (K142403)
Reference Devices
- Biomet glenoids (K160085)
Submission Summary (Full Text)
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are connected and form a single, abstract shape. The graphic is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Zimmer GmbH Annemie Rehor Kausch Senior Specialist Regulatory Affairs Sulzerallee 8 Winterthur. 8404 CH
Re: K161620 Trade/Device Name: Anatomical Shoulder Domelock Dome Centric Regulation Number: 21 CFR 888.3690 Regulation Name: Shoulder Joint Humeral (Hemi-Shoulder) Metallic Uncemented Prosthesis Regulatory Class: Class II Product Code: HSD, KWS, KWS, KWT, PHX Dated: September 29, 2016 Received: September 30, 2016
Dear Annemie 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. Iisting 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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/ResourcesforYou/Industry/default.htm. 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
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/Resourcesfor You/Industry/default.htm.
Sincerely,
# Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### Indications for Use
Form Approved: OMBN1620, Rayge T of 1 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) n/a
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 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 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 intented 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 bead 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)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains 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.
Zimmer GmbH
Sulzerallee 8
8404 Winterthur
Switzerland
# 510(k) Summary
| Sponsor: | Zimmer GmbH<br>Sulzerallee 8, P.O. Box<br>8404 Winterthur, Switzerland |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Annemie Rehor Kausch<br>Senior Specialist, Regulatory Affairs<br>Telephone: +41 58 854 82 61<br>Fax: + 41 52 244 86 58 |
| Date: | June, 10th 2016 |
| Trade Name: | Anatomical ShoulderTM Domelock® Dome centric<br>which is part of the Anatomical ShoulderTM System<br>and Anatomical ShoulderTM Domelock® System |
| Classification Product Code / | HSD - Prosthesis, Shoulder, Hemi-, Humeral,<br>Metallic Uncemented<br>KWS - Prosthesis, Shoulder, Semi-Constrained,<br>Metal/Polymer Cemented<br>KWT - Prosthesis, Shoulder, Non-Constrained,<br>Metal/Polymer Cemented<br>PHX – Shoulder Prosthesis, Reverse Configuration |
| Device Classification Name: | Shoulder Prosthesis |
| Regulation Number / Description: | 21 CFR § 888.3690 – Shoulder joint humeral<br>(hemishoulder) metallic uncemented prosthesis<br>21 CFR § 888.3660 – Shoulder joint metal/polymer<br>semi-constrained cemented prosthesis<br>21 CFR § 888.3650 – Shoulder joint metal/polymer<br>non-constrained cemented prosthesis |
| Predicate Device: | Anatomical ShoulderTM Domelock® Dome centric<br>which is part of the Anatomical ShoulderTM System<br>Anatomical ShoulderTM Domelock® |
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| | Shoulder™ Fracture System, K142403, cleared<br>November 24, 2014.<br>Update of the IFU for this system for compatibility<br>with Biomet glenoids has been cleared by K160085<br>on March 8, 2016 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Description: | The Anatomical Shoulder System is a modular<br>shoulder prosthesis designed to be used in primary o<br>revision, total or hemi shoulder arthroplasty. |
| | Anatomical Shoulder Humeral Stems are available as<br>either cemented or uncemented designs. Cemented<br>stems are available in longer designs to support<br>revision cases. All Humeral Stems possess a female<br>oval taper geometry, which is the basis for all<br>modularity with compatible mating components. |
| | The Anatomical Shoulder Domelock System consists<br>of a Humeral Head which is connected to the<br>Anatomical Shoulder humeral stems using an<br>adjustable Domelock Dome centric including an<br>Expansion Ball and Expansion-pin. The Domelock<br>Dome is used to set the orientation of the Domelock<br>Humeral Heads. The male oval cone taper of the<br>Domelock expansion ball component is compatible<br>with all Humeral Stems of the Anatomical Shoulder<br>System. |
| | The assembled humeral component may be used<br>alone for hemiarthroplasty or combined with the<br>glenoid component of the Anatomical Shoulder<br>System or with the Biomet Modular Hybrid or all-<br>polyethylene Keeled Glenoid for total arthroplasty. |
| Intended Use of the AS System: | The Anatomical Shoulder Domelock System is<br>intended for long-term implantation into the human<br>shoulder joint in primary or revision, total or hemi<br>shoulder arthroplasty. The system is intended to<br>relieve pain and restore function in patients with<br>adequate bone stock to support the prosthesis. |
| Indications for Use of the AS System: | Hemi or Total Arthroplasty Application of the<br>Anatomical Shoulder Humeral Stems and Domelock<br>System<br>The Anatomical Shoulder Humeral Stems and<br>Domelock System are indicated for |
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- · Advanced wear and tear of the shoulder ioint 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
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| | The Anatomical Shoulder Fracture System is intended<br>for use in prosthetic replacement of the proximal<br>humerus and the glenoid articular surface of the<br>scapula during total-, hemi and fracture shoulder<br>arthroplasty in treatment of the following:<br>• Complex 3- and 4-part fractures of the proximal<br>humerus with subluxation of the head fragment<br>• Complex 3- and 4-part fractures of the proximal<br>humerus with loosening of the spongiosa in the head<br>fragment<br>• Complex 3- and 4-part fractures of the proximal<br>humerus with additional cross split of the head<br>fragment<br>• Fracture instability after osteosynthesis of 3- and 4-<br>part fracture fragments of the proximal humerus<br>• Posttraumatic necrosis of the humeral head<br>• Posttraumatic arthrosis after humeral head fracture<br>The Humeral Fracture Stems are intended for either<br>cemented or uncemented use. When used in a total<br>shoulder application, the Anatomical Shoulder<br>Pegged and Keeled Glenoids Cemented are intended<br>for cemented use only. |
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| Comparison to Predicate Device: | Three modifications to the Anatomical Shoulder<br>Domelock Dome centric are proposed:<br>1) The oval taper of the expansion ball is splitted<br>into a 9.3 mm long oval taper and a 2.2 mm long<br>oval cylinder to avoid interference with the rasps<br>during trialing.<br>2) The thickness of a laser mark line which is used<br>for correct alignement of expansion ball and stem<br>is increased for improved readability.<br>3) The inner diameter of the Dome is increased by<br>0.01 mm to improve ease of trialing. |
| | The indications for use/intended use are unchanged.<br>The materials remain the same and the fundamental<br>technology is unchanged. |
| Performance Data (Nonclinical<br>and Clinical) | The results of non-clinical analyses demonstrate that<br>the devices are safe and effective and substantially<br>equivalent to the predicate devices. Performance<br>analyses included:<br>1. Functional relationship analysis<br>2. Finite Element Analysis for fatigue strength. |
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Clinical Performance and Conclusions: Clinical data and conclusions were not needed to demonstrate
substantial equivalence.
