The SMR Shoulder system is intended for partial or total primary shoulder joint replacement. The components are intended for use in cemented and uncemented applications, as specified in the following table:

COMPONENT	USE
	Cemented	Uncemented
Cemented stems	X
Cementless Finned stems		X
Trauma Humeral Bodies	X	X
Finned Humeral Bodies	X	X
Humeral Heads	X	X
Adaptor Tapers	X	X
Cemented Glenoids	X

Total or hemi-shoulder replacement is indicated for patients suffering from disability due to:

· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
· Inflammatory degenerative joint disease such as rheumatoid arthritis;
· Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods

Device Description

The SMR Shoulder System consists of a humeral stem, a humeral body, an adaptor taper, a humeral head and a glenoid components are offered for hemi or total shoulder joint arthroplasty, in primary trauma surgery. Humeral components are provided in different designs and are intended for cementless use while glenoid components are intended for cemented use only.

Two designs of humeral stems are available: the first one (object of this submission) is intended for uncemented use while the second one (submitted in 510(k): K100858) is intended for cemented use only.

Two lengths of uncemented humeral stems are available: 60 and 80 mm. The 60 mm stems are characterized by an outline with a double conicity and they are finned to provide optimal proximal fixation. The stem is sand-blasted. The 80 mm stems are characterized by an outline with a triple conicity and are also finned to provide optimal fixation. The proximal part is sand-blasted while the distal part is polished. All stems are made from Ti6Al4V (ISO 5832-3, ASTM F1472). The stems are provided with a male Morse taper (identical to that described in K100858) to allow coupling with the humeral bodies.

Humeral bodies are available in two designs. The first one (submitted in 510(k): K100858) is characterized by holes for humeral bone reconstruction as a consequence of trauma while the second one (object of this 510(k)) is finned to allow proximal press-fit fixation of the humeral system. Both designs of humeral bodies can be used in cemented (with cemented stems submitted in 510(k): K100858) and in uncemented applications (with uncemented stems submitted in this 510(k). Humeral bodies are made from Ti6Al4V (ISO 5832-3, ASTM F1472).

They are coupled with the humeral stem via a female Morse-taper connection; a locking screw is provided to aid in initial mating of the stem / body assembly.. Cylindrical marks are designed at the base of this Morse-taper to provide correct alignment of the eccentricity of the humeral head during surgery. A male Morse-taper connection is designed for the coupling between the humeral body and the humeral head by means of specific adaptor tapers: an angle of 45° between the axis of this Morse-taper and the axis of the stem gives the correct varus-valgus alignment to the joint.

The device descriptions for the adaptor tapers, humeral heads and glenoid components submitted in K100858 are repeated here in italic typing for a better understanding of the complete system.

Adaptor tapers (neutral and eccentrical with different heights), are made from Ti6Al4V. They allow coupling between the humeral body and the humeral head. These devices are designed to adjust the centre of rotation of the joint and provide the required offset to the humeral head to achieve the correct tensioning to the soft tissues, optimizing joint stability.

The humeral heads are made from CoCrMo (ISO 5832-12, ASTM F1537). They are intended to articulate with the glenoid bone in hemi-arthroplasty or with the glenoid component in total shoulder arthroplasty. The surface is polished to aid in the reduction of wear.

The glenoid components are manufactured from Ultra-High Molecular Weight Polyethylene (UHMWPE ISO 5834-2, ASTM F648). The articulating surface has a radius of curvature greater than the corresponding humeral head, which allows translation in the superior/inferior and anterior/posterior directions. The back surface of the component is spherical in geometry and has a single central peg which is inserted in the hole drilled in the glenoid cavity during surgery. The peg surface has three grooves to provide enhanced cement fixation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the SMR Uncemented Shoulder System:

Based on the document K101263, the SMR Uncemented Shoulder System is a medical device (shoulder prosthesis). The submission is a 510(k) premarket notification, which means the manufacturer is asserting substantial equivalence to existing legally marketed predicate devices, rather than proving safety and effectiveness through extensive clinical trials.

The provided document does not describe a study involving a particular "device" that makes predictions against a "ground truth" using metrics, nor does it provide acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or F1-score. This type of information is typically associated with AI/ML-driven or diagnostic devices.

Instead, this document describes a traditional medical device (implantable prosthesis) and its premarket submission. The "acceptance criteria" and "study" are interpreted here in the context of device design verification and validation, demonstrating substantial equivalence to predicate devices, focusing on mechanical performance and material compatibility.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical device submission and not an AI/ML or diagnostic device, the "acceptance criteria" relate to mechanical performance and material compatibility, demonstrated through non-clinical testing. The document states that a detailed table or specific quantitative acceptance criteria and their corresponding results are not provided in this summary. Instead, a general statement of compliance is made.

Acceptance Criteria Category	Reported Device Performance	Comments
Mechanical Performance		The document states: "All mechanical testing was done on worst case components or constructs. Where possible, standard test methods were used to allow comparison to testing of the predicate devices. The testing results demonstrated the device's ability to perform under expected clinical conditions."
Static Pull-out Testing	Passed	Performed on all modular connections. Specific quantitative values are not provided in this summary.
Torsional Testing	Passed	Performed on all modular connections. Specific quantitative values are not provided in this summary.
Fatigue Testing	Passed	Demonstrated strength of humeral stem and post-fatigue strength of modular connections. Specific quantitative values are not provided in this summary.
Static Shear Testing	Passed	Performed on the glenoid component. Specific quantitative values are not provided in this summary.
Torsional Testing	Passed	Performed on the glenoid component. Specific quantitative values are not provided in this summary.
	Passed	Performed on the glenoid component. Specific quantitative values are not provided in this summary.
Material Compatibility	Matched/Similar	Components manufactured from the same or similar materials as predicate devices (e.g., Ti6Al4V, CoCrMo, UHMWPE).
Intended Use / Indications	Similar to Predicates	The SMR Shoulder System's intended use and indications are similar to those of predicate devices, with the exception of not being indicated for revision procedures.
Design	Similar to Predicates	Modular design elements are similar to predicate devices, though some variations exist (e.g., presence/absence of adaptor tapers).

Regarding the other requested points (2-9), these are typically relevant for AI/ML or diagnostic device studies, and are not applicable to this traditional mechanical medical device submission.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This refers to non-clinical mechanical testing, not a data-driven test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on engineering standards and measurements, not expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device is an implant, not a diagnostic tool or an AI-assisted device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For non-clinical tests, the "ground truth" is defined by established engineering principles, material science, and physical measurement standards (e.g., ASTM, ISO).
8. The sample size for the training set: Not applicable. There is no "training set" in the context of this traditional device submission.
9. How the ground truth for the training set was established: Not applicable.

Study that proves the device meets the acceptance criteria:

The study proving the device meets the acceptance criteria is detailed in the "Non-Clinical Testing" section of the document.

Type of Study: Non-Clinical Mechanical Testing.
Tests Performed:
- Static pull-out testing of all modular connections.
- Torsional testing of all modular connections.
- Fatigue testing to demonstrate humeral stem strength and post-fatigue strength of modular connections.
- Static shear testing of the glenoid component.
- Torsional testing of the glenoid component.
- Fatigue testing of the glenoid component.
Test Conditions: Testing was performed on "worst case components or constructs."
Methodology: "Where possible, standard test methods were used to allow comparison to testing of the predicate devices." (Specific standards like ISO or ASTM are not explicitly named in this summary but are commonly used for such tests).
Results/Conclusion: "The testing results demonstrated the device's ability to perform under expected clinical conditions."
Clinical Testing: The document explicitly states: "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Shoulder System to the predicate device(s)." This reinforces that the primary evidence for this 510(k) submission comes from non-clinical mechanical testing and comparison to predicate devices, rather than human trials for safety and effectiveness.

Summary

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K101263

p. 1/3

JAN 2 8 2011

Summary of Safety and Effectiveness

Date: April 28, 2010

Manufacturer: Lima-Lto S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy

U.S. Contact Person: Cheryl Hastings Principal Consultant Phone: 574-527-4220

Product	Product Code	Regulation and Classification Name
SMR UncementedShoulder System	KWT	Shoulder joint metal/polymer non-constrainedcemented prosthesis per 21 CFR 888.3650
	HSD	Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesis per 21 CFR 888.3690

Device Description:

Traditional 510(k) – SMR Uncemented Shoulder System April 28, 2010

Company Confidential Section 5 – Page 17 of 264

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$$\xi \lor \Delta \langle \bullet \rangle$$

. p.2/3

The device descriptions for the adaptor tapers, humeral heads and glenoid components submitted in K100858 are repeated here in italic typing for a better understanding of the complete system.

Intended Use / Indications:

COMPONENT	USE
	Cemented	Uncemented
Cemented stems	X
Cementless Finned stems		X
Trauma Humeral Bodies	X	X
Finned Humeral Bodies	X	X
Humeral Heads	X	X
Adaptor Tapers	X	X
Cemented Glenoids	X

Total or hemi-shoulder replacement is indicated for patients suffering from disability due to:

Traditional 510(k) – SMR Uncemented Shoulder System April 28, 2010

Company Confidential Section 5 – Page 18 of 264

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· Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
· Inflammatory degenerative joint disease such as rheumatoid arthritis;

K101263

· Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods

Predicate Devices:

Promos modular shoulder system (PlusOrthopedics, K032126, K063578); ●
Anatomical shoulder system (Centerpulse, K030259); �
Modular Shoulder System (Acumed, K992525) .

Comparable Features to Predicate Device(s):

The SMR Shoulder System is similar to the predicate devices in terms of intended use, indications, design and materials. The SMR Shoulder System and the predicates are all intended for partial or total primary shoulder joint replacement. The SMR humeral stems,are intended for cemented or uncemented use, depending on the design, as are the predicate humeral stems. The indications of all of the systems are similar with the exception that the SMR Shoulder System is not indicated for revision procedures.

Like the Promos Modular and Acumed Modular Shoulder Systems, the SMR Shoulder System provides modular humeral stem and humeral body components. The Anatomical Shoulder System is designed as a one-piece humeral stem / body component. The SMR Shoulder System and the Promos Modular Shoulder System include modular adaptor tapers for adjustment of the humeral head. The Anatomical Shoulder System and the Acumed Modular Shoulder System do not include adaptor tapers.

The components of the SMR Shoulder System are manufactured from the same or similar materials as the predicate devices. The SMR, Promos and Acumed humeral stems are manufactured from Ti6Al4V while the Anatomical cemented humeral stems are manufactured from cast CoCrMo.

Non-Clinical Testing: The SMR Shoulder System has undergone static pull-out and/or torsional testing of all modular connections; fatigue testing to demonstrate both the strength of the humeral stem and the post-fatigue strength of the modular connections; static shear and torsional testing of the glenoid component; and fatigue testing of the glenoid component. All mechanical testing was done on worst case components or constructs. Where possible, standard test methods were used to allow comparison to testing of the predicate devices. The testing results demonstrated the device's ability to perform under expected clinical conditions.

Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the SMR Shoulder System to the predicate device(s).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Limacorporate S.p.A. % Hastings Regulatory Consulting, LLC. Ms. Cheryl Hastings Principal Consultant P.O. Box 696 Winona Lake, Indiana 46590

JAN 2 8 2311

Re: K101263

Trade/Device Name: SMR Uncemented Shoulder System Regulation Number: 21 CFR 888.3650 Regulation Name: Shoulder joint metal/polymer non-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWT, HSD Dated: January 10, 2011 Received: January 19, 2011

Dear Ms. Hastings:

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

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Page 2 – Ms. Cheryl Hastings

device-related adverse events) (21 CFR 803); good manufacturing practive 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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 yours,

A. B. R.
for-

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K101263

$\rho.i//$

510(k) Number (if known): Unknown Device Name: SMR Uncemented Shoulder System Indications for Use:

SMR Uncemented Shoulder System Indications for Use

COMPONENT	USE
	Cemented	Uncemented
Cemented stems	X
Cementless Finned stems		X
Trauma Humeral Bodies	X	X
Finned Humeral Bodies	X	X
Humeral Heads	X	X
Adaptor Tapers	X	X
Cemented Glenoids	X

Total or hemi-shoulder replacement is indicated for patients suffering from disability due to:

· Non-inflammatory degenerative joint disease including osteoarthritis and vascular necrosis;
Inflammatory degenerative joint disease such as rheumatoid arthritis; .
· Treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 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) for M.Meikerson

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101263

Page 1 of 1

Traditional 510(k) - SMR Uncemented Shoulder System April 28, 2010

Company Confidential Section 4 = Page 16 of 264

Regulation Number and Section

§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”