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 fragments of the proximal humerus;
Posttraumatic necrosis of the humeral head;
Posttraumatic arthrosis after humeral head fracture.
The Anatomical Shoulder Fracture stem is intended for cemented or cementless use.

Device Description

The Anatomical Shoulder Fracture System is designed specifically to treat complex 3 or 4 part proximal humerus fractures requiring hemi- or total shoulder arthroplasty. The Anatomical Shoulder Fracture System may be used with or without bone cement. The Anatomical Shoulder Fracture System consists of four components, a stem, baseplate, screw and head. The Anatomical Shoulder Fracture System baseplate offers right and left side-specific versions in order to appropriately match the original shoulder anatomy with respect to right and left humeral anatomy. The Anatomical Shoulder Fracture System head is also designed to articulate with the glenoid components of the Anatomical Shoulder System (K030259). The Anatomical Shoulder Fracture System stem is also designed to accept the Anatomical Shoulder Inverse/Reverse humeral cup (K053274) for conversion from hemi- or total shoulder arthroplasty to an inverse/reverse shoulder arthroplasty in situations when the rotator cuff is irreparable and the patient is experiencing severe instability of the shoulder joint. The Anatomical Shoulder Fracture System stem is comparable in shape and size to stems traditionally used for hemi- and total shoulder arthroplasty. The Anatomical Shoulder Fracture System stem, however, has two features which distinguish it as a stem designed for treatment of proximal humeral fractures. The proximal surface of the humeral stem and much of the surface of the baseplate offer spikes which assist in the stable anchoring of the humeral tuberosities to the stem and allow for primary stability of the tuberosities. The Anatomical Shoulder Fracture System stem and baseplate also offer several suture holes to allow initial stable fixation of the humeral tuberosities with sutures.

AI/ML Overview

The provided text is a 510(k) summary for the Zimmer Anatomical Shoulder™ Fracture System, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Key takeaways regarding acceptance criteria and studies:

The document states: "Performance testing indicates that all components meet or exceed predetermined performance criteria for their intended use." However, it does not provide specific numerical acceptance criteria for the device's performance, nor does it detail the specific study designs, methodologies, or results that prove these criteria were met.

Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices, an approach common for 510(k) submissions. This means that the device is considered safe and effective because it is similar in intended use, design, materials, and manufacturing methods to devices already on the market.

Therefore, many of the requested details about specific acceptance criteria and detailed study information are not available in the provided text because it's a summary focused on substantial equivalence rather than a full study report with performance metrics.

Here's a breakdown of what can be inferred or stated as "not applicable/provided" based on the input:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Specific numerical acceptance criteria for performance	Not provided in this summary. The document broadly states: "Performance testing indicates that all components meet or exceed predetermined performance criteria for their intended use." This is an assertion of compliance rather than a report of specific metrics or a table of results.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size for the test set: Not provided.
Data provenance: Not provided. The document mentions "Performance testing" but does not specify if this involved patient data, laboratory tests, or simulation, nor does it give origin or nature (retrospective/prospective). Given it's a 510(k) for an implant, the "performance testing" likely refers to non-clinical bench testing rather than clinical patient studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not applicable/Not provided. As no clinical "test set" in the context of expert review (e.g., for image interpretation) is described, expert ground truth establishment for such a test set is not relevant here.
Qualifications of experts: Not applicable/Not provided.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Adjudication method: Not applicable/Not provided. No clinical test set requiring adjudication by experts is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC comparative effectiveness study: No. This device is an orthopedic implant, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or described.
Effect size of human readers with/without AI: Not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone performance: Not applicable. This device is a physical shoulder implant, not a software algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Type of ground truth: Performance testing for an orthopedic device typically involves biomechanical testing or material testing against engineering standards or established performance benchmarks for similar devices. The "ground truth" would be the measurable physical properties and performance under specific simulated conditions (e.g., fatigue life, strength, range of motion, wear characteristics). The document simply states "Performance testing indicates that all components meet or exceed predetermined performance criteria," implying such testing was conducted but not detailing the 'ground truth' benchmarks.

8. The sample size for the training set

Sample size for the training set: Not applicable/Not provided. This device is not an AI/ML algorithm that requires a "training set" in the computational sense. If "training set" refers to design and testing iterations, these details are not in the summary.

9. How the ground truth for the training set was established

How ground truth for the training set was established: Not applicable/Not provided. As this is not an AI/ML device, the concept of a training set with established ground truth is not relevant here.

Summary

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K062029

OCT 3 1 2006

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Summary of Safety and Effectiveness

Submitter:	Zimmer GmbHP.O. BoxCH-8404 Winterthur, Switzerland
Contact Person:	Mason W. RobbinsRegulatory Affairs Specialist, Regulatory AffairsTelephone: (574) 371-8065Fax: (574) 372-4605
Date:	July 17, 2006
Trade Name:	Anatomical Shoulder™ Fracture System
Common Name:	Hemi- and Total Shoulder Arthroplasty Prosthesis
Classification Nameand Reference:	prosthesis, shoulder, semi-constrained,metal/polymer cemented; 21 CFR § 888.3660;prosthesis, shoulder, hemi-, humeral, metallicuncemented, 21 CFR § 888.3690
Predicate Devices:	Aequalis Shoulder Fracture System & AequalisShoulder, manufactured by Tornier S.A., K060209,cleared March 2, 2006Global Fx Humera! Stem and Global AdvantageHumeral Head, manufactured by DepuyOrthopedics, Inc., K984541, cleared January 14,1999.Zimmer Trabecular Metal™ Reverse ShoulderSystem, manufactured by Zimmer, Inc., K052906,cleared December 19, 2005.Anatomical Shoulder, manufactured Zimmer GmbH(Formerly Centerpulse Orthopedics), K030259,cleared April 24, 2003.
Device Description:	The Anatomical Shoulder Fracture System isdesigned specifically to treat complex 3 or 4 partproximal humerus fractures requiring hemi- or totalshoulder arthroplasty. The Anatomical ShoulderFracture System may be used with or without bonecement. The Anatomical Shoulder Fracture System

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Kd2029 2/

consists of four components, a stem, baseplate. screw and head. The Anatomical Shoulder Fracture System baseplate offers right and left side-specific versions in order to appropriately match the original shoulder anatomy with respect to right and left humeral anatomy.

The Anatomical Shoulder Fracture System head is also designed to articulate with the glenoid components of the Anatomical Shoulder System (K030259). The Anatomical Shoulder Fracture System stem is also designed to accept the Anatomical Shoulder Inverse/Reverse humeral cup (K053274) for conversion from hemi- or total shoulder arthroplasty to an inverse/reverse shoulder arthroplasty in situations when the rotator cuff is irreparable and the patient is experiencing severe instability of the shoulder joint.

The Anatomical Shoulder Fracture System stem is comparable in shape and size to stems traditionally used for hemi- and total shoulder arthroplasty. The Anatomical Shoulder Fracture System stem, however, has two features which distinguish it as a stem designed for treatment of proximal humeral fractures. The proximal surface of the humeral stem and much of the surface of the baseplate offer spikes which assist in the stable anchoring of the humeral tuberosities to the stem and allow for primary stability of the tuberosities. The Anatomical Shoulder Fracture System stem and baseplate also offer several suture holes to allow initial stable fixation of the humeral tuberosities with sutures.

The Anatomical Shoulder Fracture System is substantially equivalent to the predicate devices in regards to its intended use, design, size ranges, materials and manufacturing methods.

Non-Clinical Performance and Conclusions: Performance testing indicates that all components meet or exceed predetermined performance criteria for their intended use.

Comparison to Predicate Devices:

Performance Data (Nonclinical and/or Clinical):

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three human figures are nestled within the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

OCT 3 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zimmer, Inc % Mr. Mason W. Robbins, MS, RPCV, CCRP Regulatory Affairs Specialist P.O. Box 708 Warsaw, Indiana 46581-0708

Re: K062029

Trade/Device Name: Anatomical Shoulder™ Fracture System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: KWS, HSD Dated: October 13, 2006 Received: October 16, 2006

Dear Mr. Robbins:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Mason W. Robbins, MS, RPCV, CCRP

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain/html

Sincerely vours.

Mark N. Molkerson, M.S.

Mark N. Melkerson, M.S. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K662029

Indications for Use

510(k) Number (if known):

Device Name:

Anatomical Shoulder™ Fracture System

Indications for Use:

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 fragments of the proximal humerus; .
. Posttraumatic necrosis of the humeral head;
. Posttraumatic arthrosis after humeral head fracture.

The Anatomical Shoulder Fracture stem is intended for cemented or cementless use.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(Please do not write below this line - Continue on another page if needed)

Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number K061064

Regulation Number and Section

§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,” and
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-aluminum 4-vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-chromium-molybdenum casting alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-chromium-molybdenum alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra-high Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”