Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System

Q: Who is the manufacturer of Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System?

Zimmer GmbH filed the 510(k) submission for Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System (K142403).

Q: What is the FDA product code for Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System?

KWS. It is classified under 21 CFR 888.3660 as a Class 2 device in the Orthopedic panel.

Q: What is the regulatory pathway for Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System?

Anatomical Shoulder with Removable Head (K030259); Anatomical Shoulder Fracture System (K062029).

Q: Who can help prepare an FDA 510(k) submission like Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K142403 · Zimmer GmbH · KWS · Nov 24, 2014 · Orthopedic

Device Facts

Record ID	K142403
Device Name	Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture System
Applicant	Zimmer GmbH
Product Code	KWS · Orthopedic
Decision Date	Nov 24, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 888.3660
Device Class	Class 2
Attributes	Therapeutic

Intended 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 are intended for cemented use only. 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 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 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.

Device Story

Modular shoulder prosthesis system for primary or revision total/hemi arthroplasty; includes humeral stems, Domelock system, and fracture system components. Stems feature female oval taper geometry for modularity with humeral heads or reverse components. Domelock system allows adjustable orientation of humeral heads via dome centric or fixed-angle T-Domes. Fracture system includes stems, heads, baseplates, and locking screws for proximal humerus reconstruction. Used in hospital settings by orthopedic surgeons. Implants provide structural replacement of shoulder joint surfaces to relieve pain and restore function. Permanent implantation.

Clinical Evidence

No clinical data provided. Substantial equivalence demonstrated via non-clinical performance testing and analyses, including literature review, morphological/range of motion analysis (ASTM F1378-12), finite element analysis, fatigue testing (ASTM F1378-12), connection strength testing (ASTM F2009-00), humeral stem fixation testing, and joint contact stress analysis.

Technological Characteristics

Modular shoulder prosthesis. Materials: Protasul-100 (Ti6Al7Nb, ASTM F1295-11), Protasul-21WF (Co28Cr6Mo, ASTM F1537-11), Protasul-64WF (Ti6Al4V, ASTM F136-13). Features female oval taper geometry for modular assembly. Sterilization: Gamma irradiation. Components designed for cemented or uncemented (press-fit) fixation.

Indications for Use

Indicated for patients requiring primary, fracture, or revision total/hemi shoulder arthroplasty due to degenerative, posttraumatic, or rheumatoid arthritis, avascular necrosis, omarthrosis, or complex proximal humerus fractures. Requires adequate bone stock and functional deltoid muscle for reverse applications.

Regulatory Classification

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).

Special Controls

*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.”

Predicate Devices

Anatomical Shoulder with Removable Head (K030259)
Anatomical Shoulder Fracture System (K062029)

Related Devices

K161620 — Anatomical Shoulder Domelock Dome centric · Zimmer GmbH · Nov 1, 2016
K160085 — Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System · Zimmer GmbH · Mar 8, 2016
K112438 — TITAN MODULAR TOTAL SHOULDER SYSTEM · Ascension Orthopedic · Apr 11, 2012
K001706 — WMT MODULAR SHOULDER SYSTEM · Wrightmedicaltechnologyinc · Aug 16, 2000
K002683 — WMT ULTRA-FIT MODULAR SHOULDER SYSTEM · Wrightmedicaltechnologyinc · Nov 22, 2000

Submission Summary (Full Text)

{0}------------------------------------------------ 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 caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 24, 2014 Zimmer GMBH Dr. Annemie Rehor Kausch Senior Specialist Regulatory Affairs Sulzerallee 8 8404 Winterthur, Switzerland Re: K142403 Trade/Device Name: Anatomical Shoulder™ System/Anatomical Shoulder™ Domelock®/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, PHX, KWT, HSD Dated: August 25, 2014 Received: August 27, 2014 Dear Dr. 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical {1}------------------------------------------------ device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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) not known #### 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 are intended for cemented use only. 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 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 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) {3}------------------------------------------------ #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Zimmer Biomet. The logo features a large, stylized blue "Z" inside of a blue circle. Below the circle, the word "zimmer" is written in lowercase blue letters, using a sans-serif font. Zimmer GmbH Sulzerallee 8 8404 Winterthur Switzerland # 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: | November, 24th 2014 | | Trade Name: | Anatomical Shoulder™ System Anatomical Shoulder TM Domelock® Anatomical Shoulder TM 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 with Removable Head, manufactured by Zimmer GmbH, K030259, cleared April 24, 2003 Anatomical Shoulder Fracture System, | {5}------------------------------------------------ manufactured by Zimmer GmbH, K062029, cleared October 31, 2006) ### 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. All Humeral Stems possess a female oval taper geometry, which is the basis for all modularity with compatible mating components. For a hemi or total arthroplasty application, the stems can be combined with the proposed Anatomical Shoulder Domelock System, the existing Anatomical Shoulder Ball-taper Humeral Head System or the existing Anatomical Shoulder Bigliani/Flatow Adaptor. For a reverse application the stems are combined with the existing Anatomical Shoulder Inverse/Reverse components. The Anatomical Shoulder Domelock System consists of a Humeral Head which is connected to the Anatomical Shoulder Stems using either an adjustable Domelock Dome centric including a Ball-taper and Expansion-pin, or a series of fixed-angle T-Domes. The Domelock Dome and T-Domes are used to set the orientation of the Domelock Humeral Heads. The male oval cone taper of the Domelock component is compatible with all Humeral Stems of the Anatomical Shoulder System. The assembled humeral component may be used alone for hemiarthroplasty or combined with the existing glenoid component of the Anatomical Shoulder System for total arthroplasty. The Anatomical Shoulder Fracture System consists of a Humeral Fracture Stem and a Humeral Head Fracture including a Fracture Baseplate and a Looking Screw. 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. The Anatomical Shoulder Humeral Head Fracture offers right and left side-specific versions. The assembled {6}------------------------------------------------ Anatomical Shoulder Fracture humeral component may be used alone for hemiarthroplasty or combined with the glenoid component of the Anatomical Shoulder System for total arthroplasty. The Anatomical Shoulder Fracture Stem is also designed to accept the existing Anatomical Shoulder Inverse/Reverse components and the existing Anatomical Shoulder Bigliani/Flatow Adaptor. The Humeral Stems and Baseplates are made from Protasul-100 (Ti6Al7Nb. ASTM F1295-11). The Domelock Humeral Heads, the Fracture Heads and the Fracture Screw are made from Protasul-21WF (Co28Cr6Mo, ASTM F1537-11). The Domelock head locking mechanism is made from Protasul-100 and Protasul-64WF (Ti6A14V, ASTM F136-13). The materials are anticipated to have permanent contact. All components are provided sterile (gamma irradiated) for use implantation in a hospital. 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 - · 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 Intended Use: {7}------------------------------------------------ Pegged and Keeled Glenoids Cemented are intended for cemented use only. ### 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 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 4part 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 {8}------------------------------------------------ Pegged and Keeled Glenoids Cemented are intended for cemented use only. Comparison to Predicate Device: The proposed devices are line extensions to the predicate devices. They share the same indications for use/intended use, utilize the same materials and manufacturing processes, and have similar technical features as their predicates. Performance Data (Nonclinical The results of non-clinical performance testing and and/or Clinical): analyses demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing and/or analyses included: 1. Literature review 2. Morphological and Range of Motion Analysis (ASTM F1378-12) 3. Finite Element Analysis and Fatigue testing (ASTM F1378-12) 4. Connection strength testing (ASTM F2009-00) 5. Humeral stem fixation testing 6. Joint Contact stresses analysis > Clinical Performance and Conclusions: Clinical data and conclusions were not needed to demonstrate substantial equivalence.