ARROW ANATOMICAL SHOULDER SYSTEM

K093599 · Fournitures Hospitalieres Industrie · KWS · Nov 24, 2010 · Orthopedic

Device Facts

• Record ID: K093599
• Device Name: ARROW ANATOMICAL SHOULDER SYSTEM
• Applicant: Fournitures Hospitalieres Industrie
• Product Code: KWS · Orthopedic
• Decision Date: Nov 24, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The anatomical shoulder system, depending on the components used, is designed for: Simple humeral prosthesis: - Fracture dislocation or complex four part fracture of the proximal humerus - - Humeral head necrosis without injury to the glenoid cavity. - - Extensive humeral head cartilage damage without injury to the glenoid cavity - - Centered osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant. - Rheumatoid polyarthritis with thin rotator cuff. - - Off-centered osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°. Total anatomical prosthesis (cemented glenoid implant with 4 pegs) AND/OR - Centered glenohumeral osteoarthritis with functional rotator cuff - -Rheumatoid polyarthritis with functional rotator cuff - . Fracture sequela, functional rotator cuff with glenoid injury.

Device Story

Modular shoulder prosthesis; components include humeral stems, humeral heads (centered/off-centered), and cemented glenoids. Implanted by orthopedic surgeons in clinical/hospital settings using dedicated instrumentation. Replaces damaged shoulder joint surfaces to restore function and reduce pain. Clinical benefit derived from mechanical reconstruction of glenohumeral joint. No software or algorithm involved.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM F1738-05, ASTM F1829-98, and ASTM F2028-05 for glenoid components. No clinical data provided.

Technological Characteristics

Modular shoulder prosthesis. Materials: titanium alloy (humeral stem), cobalt chromium alloy (humeral head), polyethylene (cemented glenoid). Mechanical fixation via cementation or uncemented humeral stem. Standards: ASTM F1738-05, ASTM F1829-98, ASTM F2028-05.

Indications for Use

Indicated for patients requiring shoulder arthroplasty due to proximal humeral fractures, humeral head necrosis, extensive cartilage damage, osteoarthritis (centered or off-centered), rheumatoid polyarthritis, or fracture sequelae. Contraindicated for patients without functional rotator cuff when using total anatomical prosthesis, or when glenoid cavity is unsuitable for implantation.

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

• GlobalTM Advantage Shoulder (K984541/K992065)
• Exactech Equinoxe® Shoulder System (K042021/K061454)

Submission Summary (Full Text)

{0}------------------------------------------------

Fournitures Hospitalières industrie

ARROW® anatomical shoulder system Traditional 510(k) Premarket Notification

# K093599

alletting the state the minister in the same in a man and in a

# NOV 2 4 2010

# 5. 510(k) Summary of Safety and Effectiveness

This summary of 510(k) safety and effectiveness information is being submitted in accordance to the requirements of SDMA 1990 and 21 CFR 807.92.

Date prepared: September 2nd 2010

The assigned 510(k) number is: K0903599

| 5-1. Applicant: | Fournitures Hospitalières industrie |
|-----------------|-----------------------------------------------------------------------------------------------------------------|
| | 6 Rue Nobel, Z.I. de Kernévez<br>29000 QUIMPER - FRANCE<br>Tel: [phone]<br>Fax: [phone] |

#### 5-2. Company Contact: Franck HUNT, General Manager Tel: [phone]

### 5-3. Product :

---

ン...

、

| Trade name: | ARROW® anatomical shoulder system | |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Common name: | Shoulder prosthesis | |
| Classification: | The ARROW® anatomical shoulder system components are included in the following classifications:<br>- Shoulder joint metal/ polymer semi-constrained cemented prosthesis<br>Product code: KWS<br>Regulation: 21 CFR 888.3660<br>Class: II<br>- Shoulder joint metal/polymer non-constrained cemented prosthesis<br>Product code: KWT<br>Regulation: 21 CFR 888.3650<br>Class: II<br>- Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis<br>Product code: HSD<br>Regulation: 21 CFR 888.3690<br>Class: II | |

### 5-4. Predicate/ Legally Marketed Devices :

Information on devices to which substantial equivalence is claimed:

| Manufacturer: | DePuy Orthopaedics, Inc |
|--------------------|-----------------------------|
| Device Trade Name: | GlobalTM Advantage Shoulder |
| 510 (K): | K984541/K992065 |

{1}------------------------------------------------

Fournitures Hospitalières industrie

Manufacturer: Device Trade Name: 210 (K):

Exactech, Inc. Exactech Equinoxe® Shoulder System K042021/ K061454

#### 5-5. Device Description:

The ARROW® anatomical shoulder system is a modular shoulder prosthesis, composed of the following elements:

- humeral stems,
- humeral heads (centred or off-centred),
- cemented glenoids.

The ARROW® anatomical shoulder system is intended to be implanted using the dedicated instrumentation supplied by the manufacturer.

#### 5-6. Indications for Use/ Intended Use:

As stated in the Indications for Use section and on the product related labeling (instructions for use and commercial documents):

#### > Simple humeral prosthesis:

- Four-part proximal humeral fracture, or dislocation fracture. .
- Humeral head necrosis without injury to the glenoid cavity. -
- Extensive humeral head cartilage damage without injury to the glenoid cavity -
- Centered osteoarthritis with a glenoid cavity not allowing implantation of a . glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff. -
- Off-centered osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.
- > Total anatomical prosthesis (cemented glenoid implant with 4 pegs)
- Centered glenohumeral osteoarthritis with functional rotator cuff l
- Rheumatoid polyarthritis with functional rotator cuff -
- Fracture sequela, functional rotator cuff with glenoid injury. -

#### 5-7. Comparison of Technological Characteristics:

The ARROW® anatomical shoulder system and the selected predicate devices have the same intended use and substantial similar indications for use and share the following similarities:

- they are made out of the same materials (titanium alloy for the humeral stem, cobalt chromium alloy for the humeral head, polyethylene for the cemented glenoid),
- they are available in similar ranges of sizes, -
- they bear design features similarities.

#### 5-8. Performances:

The ARROW® anatomical shoulder system was tested according to ASTM F1738-05, ASTM F1829-98 and ASTM F2028-05 for the glenoid components.

{2}------------------------------------------------

After the testing was completed, it was determined that the ARROW® anatomical shoulder system performances were substantially equivalent to those of the selected predicate devices.

Risks to health have been addressed through the specified materials, processing controls, quality assurance and compliance to the Medical Device Good Manufacturing Practices Regulations.

#### 5-9. Substantial Equivalence:

The substantial equivalence of our products when compared to the selected predicate devices has been established following manufacturers' commercial documents, 510(k) submission's information available on FDA's website as well as conformance to standards in force.

The analysis of these technical data allows us to submit the ARROW® anatomical shoulder system as being substantially equivalent to the already cleared predicate devices selected to a draw a comparison.

All data on predicate devices which has been used to establish substantial equivatence is available in appendix 8.

#### 5-10. Conclusion:

Following the examination of all the above mentioned information, we believe that the ARROW® anatomical shoulder system is substantially equivalent to the selected predicate devices in terms of design, ranges of sizes, materials, intended use, performances, safety and effectiveness.

{3}------------------------------------------------

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

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

Fournitures Hospitalieres Industrie % Ms. Patricia Donnard Regulatory Affairs ZI de Kernevez 6 rue Nobel 29000 QUIMPER France

NOV 2 4 2010

Re: K093599

Trade/Device Name: ARROW® anatomical shoulder system Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, KWT, HSD Dated: October 25, 2010 Received: October 27, 2010

Dear Ms. Donnard:

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 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

{4}------------------------------------------------

Page 2 - Ms. Patricia Donnard

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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

lttp://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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Milham

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

Enclosure

{5}------------------------------------------------

## 4. Indications for Use

510(k) Number (if known): K093599

. NOV 2 4 2010

#### Device Name: ARROW® anatomical shoulder system This device is composed of the following elements: - humeral stems, - humeral heads (centred or off-centred), - cemented glenoids. ARROW® Indications for Use: The anatomical shoulder system, depending on the components used, is designed for:

#### Simple humeral prosthesis:

- Fracture dislocation or complex four part fracture of the proximal humerus -
- Humeral head necrosis without injury to the glenoid cavity. -
- Extensive humeral head cartilage damage without injury to the glenoid cavity -
- Centered osteoarthritis with a glenoid cavity not allowing implantation of a glenoid implant.
- Rheumatoid polyarthritis with thin rotator cuff. -
- Off-centered osteoarthritis with irreparable cuff, and with maintained active elevation of at least 120°.

#### Total anatomical prosthesis (cemented glenoid implant with 4 pegs)

AND/OR

- Centered glenohumeral osteoarthritis with functional rotator cuff -
- -Rheumatoid polyarthritis with functional rotator cuff
- . Fracture sequela, functional rotator cuff with glenoid injury.

Prescription Use: Yes (Part 21 CFR 801 Subpart D) Over the counter Use: No (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) Page of

Mark H. Milliken

(Division Sign-Oft) (Division Sign-Off)
Division of Surgical, Orthopedic,
Division of Surgices Division of Surg.
and Restorative Devices

K093594

510(k) Number .