Humeral head necrosis without injury to the glenoid cavity.
Extensive humeral head cartilage damage without injury to the glenoid cavity
Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
Rheumatoid polyarthritis with thin rotator cuff.
Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.

TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS)

Centred glenohumeral osteoarthritis with functional rotator cuff
Rheumatoid polyarthritis with functional rotator cuff
Post-traumatic sequela, functional rotator cuff with glenoid injury.

TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)

Centred glenohumeral osteoarthritis
Rheumatoid polyarthritis
Post-traumatic sequela with glenoid injury
Revision for glenoid loosening
Glenoid bone loss, where bone graft is needed
A functional rotator cuff is necessary to use this device

REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)
The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device.

For all types of prosthesis, the glenoid baseplate (metal-back or porous) is intended for cementless use with the addition of bone screws for fixation, the humeral short stem (metaphyseal stem) is intended for cementless use. At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation.

Device Description

The ARROW Humeral Short Stem Humeral System is an extension of humeral stem range of the Arrow prosthesis. The short stem is composed of a metaphyseal part and a cylindrical diaphyseal part. Both components are offered in various sizes to accommodate patient anatomy. This modular stem helps for better adaptation to each patient's anatomy. All implantable components are manufactured from medical grade titanium alloy (Ti6Al4V-ELI) per ASTM F-136/ISO 5832-3. The metaphysis has fins to provide rotational stability; it has a pure titanium plasma spray coating per ASTM 1580.

AI/ML Overview

This document is a 510(k) Pre-Market Notification from the FDA for the ARROW Short Stem Humeral System. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study of the device's performance against specific acceptance criteria.

Therefore, many of the requested elements (like acceptance criteria tables, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth methodologies) are not present in this document because they are typically part of a more extensive clinical or validation study report, not a 510(k) summary.

The document states that performance testing was conducted, but it's focused on mechanical testing, sterilization, packaging, and biocompatibility to demonstrate substantial equivalence, not clinical effectiveness against pre-defined acceptance criteria for a new clinical claim.

I will fill in the requested information based on what is available in the provided text. For categories where the information is not provided, I will explicitly state that.

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

This document does not provide a table of acceptance criteria or reported device performance in the manner of clinical efficacy or diagnostic accuracy. Instead, it states that "The results of all mechanical tests have shown them to be substantially equivalent to the predicate device."

Here's an attempt to extract the relevant tests conducted and the general outcome as described:

Test Type	Acceptance Criteria (Not explicitly stated in terms of thresholds)	Reported Device Performance (as described)
Sterilization	(Implicit: Meets ISO 11137 standards)	Validated to meet standards
Packaging	(Implicit: Meets ISO 11607 standards)	Validated to meet standards
Biocompatibility	(Implicit: Meets ISO 10993-1 standards)	Assessment and testing completed
Bacterial Endotoxin Levels	(Implicit: Acceptable levels per LAL pyrogen testing)	Evaluated using LAL pyrogen testing
Connection between stem and head	(Implicit: Meets ASTM F 2009 standards)	Performed per ASTM F 2009; Substantially equivalent to predicate
Connection between stem and humeral insert	(Implicit: Meets ASTM F 2009 standards)	Performed per ASTM F 2009; Substantially equivalent to predicate
Static test on metaphysis-diaphysis connection	(Implicit: Meets design requirements)	Performed; Substantially equivalent to predicate
Fatigue test on short stem - below connection	(Implicit: Meets design requirements)	Performed; Substantially equivalent to predicate
Fatigue test on short stem - above connection	(Implicit: Meets design requirements)	Performed; Substantially equivalent to predicate
Range of motion for anatomical prosthesis	(Implicit: Meets ASTM F1378 standards)	Performed per ASTM F1378; Substantially equivalent to predicate
Range of motion for reverse prosthesis	(Implicit: Meets ASTM F1378 standards)	Performed per ASTM F1378; Substantially equivalent to predicate
Fatigue testing	(Implicit: Meets ASTM F2580 standards)	Performed per ASTM F2580; Substantially equivalent to predicate
Corrosion testing	(Implicit: Meets design requirements)	Performed; Substantially equivalent to predicate
Connection dynamic torsional resistance	(Implicit: Meets design requirements)	Performed; Substantially equivalent to predicate
Connection static torsion	(Implicit: Meets design requirements)	Performed; Substantially equivalent to predicate

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

This information is not provided in the document. The testing described is primarily mechanical and material testing, not clinical studies involving patient data. Therefore, the concepts of "test set" or "data provenance" in a clinical sense do not apply to the reported performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document describes mechanical and material testing for a surgical implant, not a diagnostic device where "ground truth" is typically established by experts.

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

This information is not provided in the document. Adjudication methods are relevant for clinical studies, particularly those involving human interpretation of data, which is not described here.

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

This information is not provided in the document. The device is a surgical implant (shoulder prosthesis), not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance metrics are not applicable.

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

This information is not provided in the document. The device is a surgical implant, not an algorithm, so "standalone performance" in this context is not applicable.

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

This information is not provided in the document. For the mechanical and material tests described, the "ground truth" would be the engineering specifications and performance thresholds established by relevant ASTM/ISO standards and internal design requirements, rather than clinical ground truth types like pathology or outcome data.

8. The sample size for the training set

This information is not provided in the document. As this is not an AI/machine learning device, the concept of a "training set" is not applicable.

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

This information is not provided in the document. As this is not an AI/machine learning device, the concept of a "training set" and its associated ground truth is not applicable.

Summary

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November 30, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

FH Industrie % Christine Scifert Partner MRC Global, LLC 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112

Re: K202024

Trade/Device Name: ARROW Short Stem Humeral System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, HSD, KWS Dated: October 27, 2021 Received: October 28, 2021

Dear Christine Scifert:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Jiping Chen, Ph.D., M.P.H. Acting Division Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202024

Device Name ARROW Short Stem Humeral System

Indications for Use (Describe)

The prostheses from FH Industrie are designed for specific indications such as:

SIMPLE HUMERAL PROSTHESIS

Humeral head necrosis without injury to the glenoid cavity.
Extensive humeral head cartilage damage without injury to the glenoid cavity
Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
Rheumatoid polyarthritis with thin rotator cuff.
Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.

TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS)

Centred glenohumeral osteoarthritis with functional rotator cuff
Rheumatoid polyarthritis with functional rotator cuff
Post-traumatic sequela, functional rotator cuff with glenoid injury.

TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)

Centred glenohumeral osteoarthritis
Rheumatoid polyarthritis
Post-traumatic sequela with glenoid injury
Revision for glenoid loosening
Glenoid bone loss, where bone graft is needed
A functional rotator cuff is necessary to use this device

REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)

The ARROW Reverse Shoulder Prosthesis is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff. A functional deltoid muscle and adequate glenoid bone stock are necessary to use this device.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary FH Industrie ARROW Short Stem Humeral System 29 November 2021

Company:	FH INDUSTRIEZI DE KERNEVEZ-6 RUE NOBELQUIMPER Finistere, FRANCE 29000
Company Contact:	Patricia DONNARD -- FH IndustrieNaoual RAHIMI- FH Industrie
	+33 (0)2 98 55 68 95
Official Correspondent:	Christine Scifert – MRC Global, LLC(901) 831-8053
Trade Name:	ARROW Short Stem Humeral System
Common Name:	Prosthesis, Shoulder, Hemi-, Humeral, Metallic UncementedShoulder Prosthesis, Reverse ConfigurationProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Classification:	Class II
Regulation Number:	21 CFR 888.3690 (Shoulder joint humeral (hemi-shoulder) metallicuncemented prosthesis)21 CFR 888.3660 (Shoulder Prosthesis, Reverse Configuration)
Panel:	Orthopedic
Product Code:	PHX, HSD,KWS

Device Description:

Indications for Use:

The prostheses from FH Industrie are designed for specific indications such as: SIMPLE HUMERAL PROSTHESIS

Humeral head necrosis without injury to the glenoid cavity. -
-Extensive humeral head cartilage damage without injury to the glenoid cavity

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Centred osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
Rheumatoid polyarthritis with thin rotator cuff. -
Off-centred osteoarthritis with irreparable cuff, and with maintained active elevation of at least -
120°.

TOTAL ANATOMICAL PROSTHESIS (CEMENTED GLENOID IMPLANT WITH 4 PEGS)

Centred glenohumeral osteoarthritis with functional rotator cuff -
Rheumatoid polyarthritis with functional rotator cuff -
-Post-traumatic sequela, functional rotator cuff with glenoid injury.

TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)

Centred glenohumeral osteoarthritis -
-Rheumatoid polyarthritis
-Post-traumatic sequela with glenoid injury
-Revision for glenoid loosening
-Glenoid bone loss, where bone graft is needed

A functional rotator cuff is necessary to use this device

REVERSE PROSTHESIS (METAL-BACK OR POROUS GLENOID IMPLANT)

At least 2/3 of the metaphyseal component must be implanted in the proximal humeral bone to allow for adequate humeral component fixation.

Substantial Equivalence:

The subject ARROW Humeral Short Stem Humeral System components are substantially equivalent with respect to indications for use, design, dimension, and materials to the following devices, previously cleared by the FDA:

Primary Predicate:

FH Industrie, Arrow Humeral Stem - K112193

Additional Predicates:

FH Industrie, Arrow Humeral Stem - K093599, K150569
Exactech, Equinoxe Preserve Stem – K162726
DJO, Altivate Preserve - K190290
Biomet, Comprehensive Micro - K060692, K080642
Depuy Delta III – K021478

Reference devices /Biocompatiblity Predicates:

Fournitures Hospitalieres Industrie: ARROW Glenoid base porous (K162068, K171789)

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The Indications for Use, Materials, and Geometry for predicate devices are all similar to those of the subject device. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.

Performance Testing:

Sterilization (ISO 11137) and packaging (ISO 11607) validations , and biocompatibility (ISO 10993-1) assessment and testing were conducted and provided to demonstrate substantial equivalence. Bacterial endotoxin levels were evaluated using LAL pyrogen testing.

Mechanical testing, including the following was performed on the subject devices:

connection between stem and head per ASTM F 2009
connection between stem and humeral insert per ASTM F 2009 ●
static test on the connection between metaphysis and diaphysis
fatigue test on short stem - below the connection
fatigue test on short stem - above the connection
range of motion for anatomical prosthesis per ASTM F1378
range of motion for reverse prosthesis per ASTM F1378
fatigue testing per ASTM F2580
corrosion testing
connection dynamic torsional resistance
connection static torsion

The results of all mechanical tests have shown them to be substantially equivalent to the predicate device.

Conclusion

Based on the test results and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.

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.”