(222 days)
No
The document describes a mechanical implant and its intended use, with no mention of AI or ML technology.
Yes.
The device is a reverse shoulder prosthesis intended for patients with severe shoulder arthropathy and a deficient rotator cuff, which is a condition that requires treatment.
No
This device is a surgical implant (reverse shoulder prosthesis) used for treatment, not for diagnosing a condition. Its purpose is to replace a diseased or damaged shoulder joint.
No
The device description clearly states it is a "porous glenoid base" and is intended to be "implanted," indicating it is a physical implantable medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing a shoulder joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (glenoid base) designed to be surgically placed in the body.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the body (like blood, urine, or tissue) or providing information for diagnosis.
- Performance Studies: The performance studies mentioned are related to the mechanical properties and equivalence of the implant, not diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
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. The humeral stem is intended for cementless application while the glenoid baseplate (metal-back or porous) is intended for cementless application with the addition of bone screws for fixation. All the implants of shoulder prosthesis are used for primary or revision surgeries. The glenoid bases (metal-back or porous) are intended for cementless application with the addition of cortical or cancellous bone screws. The porous glenoid base must be used for a total anatomical or reverse prosthesis.
Product codes (comma separated list FDA assigned to the subject device)
PHX, KWS, KWT
Device Description
The ARROW® Reverse porous glenoid base is used in total reverse shoulder prosthesis and is designed to articulate with the ARROW® Reverse shoulder system (cleared in K112193). The porous glenoid base is used with bone screws for fixation (cleared in K112193).
The ARROW® Reverse porous glenoid is intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis: simple humeral prosthesis, total anatomical prosthesis and reverse prosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ARROW Reverse porous glenoid was tested according to the standards ASTM F1829-16, ASTM F2028-14 and ASTM F1378-12. After the tests were completed, it was determined that the ARROW Reverse porous glenoid 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 Requlations. The LAL testing meets the specified 20EU/device limit.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K112193, K142778, K162068, K132285, K052906
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K162068, K120740, K150463 and K150471, K093599
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 23, 2018
Fournitures Hospitalieres Industrie Patricia Donnard Regulatory Affairs Manager ZI de Kernevez - 6 rue Nobel Quimper 29000 FRANCE
Re: K171789
Trade/Device Name: ARROW® Reverse Porous Glenoid Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWT Dated: December 14, 2017 Received: December 18, 2017
Dear Patricia 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. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Katherine D. Kavlock -S
for 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 | Form Approved: OMB No. 0910-
0120
Expiration Date: January 31, 2017
See PRA Statement on last page |
| ------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------- |
|---|
510(k) Number (if known) K171789
Device Name
ARROW® Reverse porous alenoid
Indications for Use (Describe)
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. The humeral stem is intended for cementless application while the glenoid baseplate (metal-back or porous) is intended for cementless application with the addition of bone screws for fixation.
| 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) |
|---|---|
| ---------------------------------------------------------------------------- | --------------------------------------------------------------------------- |
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance to the requirements of 21 CFR 807.92.
Date: January 17, 2018
The assigned 510(k) number is: K171789
Applicant
Fournitures Hospitalières Industrie 6 Rue Nobel, Z.I. de Kernevez 29000 QUIMPER - FRANCE Tel: (+33) 2.98.55.68.95 Fax: (+33) 2.98.53.42.13
Company contact
Patricia DONNARD, Regulatory Affairs Manager p.donnard@fh-industrie.com Tel: (+33) 2.98.55.68.95
Naoual RAHIMI, Experienced RA Officer - Overseas Export Specialist n.rahimi@fh-industrie.com Tel: (+33) 2.98.55.68.95
Product
ARROW® Reverse porous glenoid Trade name:
- Common name: Shoulder prosthesis
Classification: Shoulder joint metal/polymer semi-constrained cemented prosthesis. Product code: PHX, KWS, KWT Regulation number: 21 CFR 888.3660 Class: Il
Information on predicate devices to which substantial equivalence is claimed
| Manufacturer: | Fournitures Hospitalières Industrie |
|---|---|
| Device Trade Name: | ARROW Reverse Shoulder System |
| 510(k): | K112193 |
| Manufacturer: | |
| Device Trade Name: | Fournitures Hospitalières Industrie |
| ARROW Reverse Shoulder long keel and short keel | |
| glenoid base | |
| 510(k): | K142778 |
| Manufacturer: | Fournitures Hospitalières Industrie |
| Device Trade Name: | ARROW Anatomical porous glenoid base |
| 510(k): | K162068 |
4
| Manufacturer: | TORNIER SAS |
|---|---|
| Device Trade Name: | AEQUALIS Reversed Shoulder Prosthesis |
| 510(k): | K132285 |
| Manufacturer: | Zimmer |
| Device Trade Name: | TRABECULAR metal, Reverse Shoulder System |
| 510(k): | K052906 |
Reference Devices:
| Manufacturer: | Fournitures Hospitalières Industrie |
|---|---|
| Device Trade Name: | ARROW Anatomical porous glenoid base |
| 510(k): | K162068 |
| Manufacturer: | Fournitures Hospitalières Industrie |
| Device Trade Name: | CoLS Fixation System |
| 510(k): | K120740 |
| Manufacturer: | Fournitures Hospitalières Industrie |
| Device Trade Name: | CALCANAIL |
| 510(k): | K150463 and K150471 |
| Manufacturer: | Fournitures Hospitalières Industrie |
| Device Trade Name: | ARROW Anatomic shoulder system |
| 510(k): | K093599 |
Device description
The ARROW® Reverse porous glenoid base is used in total reverse shoulder prosthesis and is designed to articulate with the ARROW® Reverse shoulder system (cleared in K112193). The porous glenoid base is used with bone screws for fixation (cleared in K112193).
The ARROW® Reverse porous glenoid is intended to be implanted using the dedicated instrumentation supplied by the manufacturer. This instrument set is common for all the configurations of prosthesis: simple humeral prosthesis, total anatomical prosthesis and reverse prosthesis.
Indications for use / Intended use
- Indications for use
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. The humeral stem is intended for cemented or cementless application while the glenoid baseplate (metal-back or porous) is
intended for cementless application with the addition of bone screws for fixation.
5
- . Intended use
All the implants of shoulder prosthesis are used for primary or revision surgeries.
The glenoid bases (metal-back or porous) are intended for cementless application with the addition of cortical or cancellous bone screws. The porous glenoid base must be used for a total anatomical or reverse prosthesis.
Comparison of technological characteristics
The ARROW Reverse porous glenoid and the above 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 material (titanium alloy), י
- they are available in similar ranges of sizes,
- they bear design features similarities.
Performances
The ARROW Reverse porous glenoid was tested according to the standards ASTM F1829-16, ASTM F2028-14 and ASTM F1378-12. After the tests were completed, it was determined that the ARROW Reverse porous glenoid 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 Requlations.
The LAL testing meets the specified 20EU/device limit.
Substantial equivalence
The substantial equivalence of our products, when compared to the selected predicate devices, has been established following the commercial documents, 510(k) submission's information as well as conformance to standards in force.
The analysis of these technical data allows us to submit the ARROW Reverse porous glenoid, as being substantially equivalent to the already cleared predicate devices selected to draw a comparison.
Conclusion
Following the examination of all the above mentioned information, we believe that the ARROW Reverse porous glenoid is substantially equivalent to the selected predicate devices in terms of intended use, ranges of sizes, materials, performances, safety and effectiveness.