(258 days)
No
The summary describes a physical implant (glenoid component for shoulder replacement) and its intended use and testing. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device, an anatomical prosthesis and implant, is used to treat specific medical conditions, which inherently classifies it as a therapeutic device.
No
The device is an implantable glenoid component used in total anatomical shoulder prostheses for surgical treatment of various shoulder conditions, not for diagnosing them. Its intended use lists conditions it treats, not conditions it identifies.
No
The device description clearly states it consists of physical components (glenoid insert, porous glenoid base, bone screws) and is intended for surgical implantation, indicating it is a hardware medical device.
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 treating various conditions of the shoulder joint (osteoarthritis, rheumatoid arthritis, fractures, etc.). This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant (glenoid insert and base) designed to be surgically placed in the body to articulate with other components of a shoulder prosthesis. This is consistent with a surgical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific markers, or providing diagnostic information based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physical implant used to replace or augment a damaged anatomical structure.
N/A
Intended Use / Indications for Use
THE ARROW ANATOMICAL POROUS GLENOID, DEPENDING ON THE COMPONENTS USED, IS DESIGNED FOR:
- CENTRED GLENOHUMERAL OSTEOARTHRITIS -
- RHEUMATOID POLYARTHRITIS -
- POST-TRAUMATIC SEQUELA WITH GLENOID INJURY -
- -FRACTURES OF THE PROXIMAL HUMERUS 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
THE POROUS GLENOID BASE IS INTENDED FOR CEMENTLESS APPLICATION WITH THE ADDITION OF BONE SCREWS FOR FIXATION.
Product codes (comma separated list FDA assigned to the subject device)
MBF, KWT, KWS
Device Description
The ARROW anatomical porous glenoid consists of a glenoid insert and a porous glenoid base. The porous glenoid base is used with bone screws for fixation (cleared in K112193). The glenoid inserts and the porous glenoid bases are used in total anatomical prosthesis and are designed to articulate with the ARROW anatomical shoulder system (cleared in K093599).
The ARROW anatomical 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 namely: simple humeral prosthesis, total anatomical prosthesis (cemented glenoid implant with 4 pegs), total anatomical prosthesis (porous glenoid implant), pending, and reverse prosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint
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 anatomical porous glenoid was tested according to the ASTM F 1829 and ASTM F 2028 standards. After the tests were completed, it was determined that the ARROW anatomical porous glenoid performances were substantially equivalent to those of the selected predicate devices.
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.
K093599, K112193, K142778, K030710
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.
Not Found
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
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement 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 (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 10, 2017
Fournitures Hospitalieres Industrie Patricia Donnard Regulatory Affairs Manager Z.I. de Kernevez - 6 Rue Nobel Ouimper, 29000 FR
Re: K162068 Trade/Device Name: Arrow Anatomical Porous Glenoid Regulation Number: 21 CFR 888.3670 Regulation Name: Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented Prosthesis Regulatory Class: Class II Product Code: MBF, KWT, KWT, KWS Dated: March 7, 2017 Received: March 9, 2017
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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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)
Device Name
ARROW® ANATOMICAL POROUS GLENOID
Indications for Use (Describe)
THE ARROW ANATOMICAL POROUS GLENOID, DEPENDING ON THE COMPONENTS USED, IS DESIGNED FOR:
- CENTRED GLENOHUMERAL OSTEOARTHRITIS -
- RHEUMATOID POLYARTHRITIS -
- POST-TRAUMATIC SEQUELA WITH GLENOID INJURY -
- -FRACTURES OF THE PROXIMAL HUMERUS 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
THE POROUS GLENOID BASE IS INTENDED FOR CEMENTLESS APPLICATION WITH THE ADDITION OF BONE SCREWS FOR FIXATION
Type of Use (Select one or both, as applicable)
区Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (1/14)
Page 1 of 1 FDA
PSC Publishing Services (301) 443-6740 EF
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510(k) Summary of safety and effectiveness
This summary of 510(k) safety and effectiveness information is submitted in accordance to the requirements of SDMA 1990 and 21 CFR 807.92.
Date prepared: July 20th 2016
The assigned 510(k) number is: K162068
1. Applicant
Fournitures Hospitalières industrie 6 Rue Nobel, Z.I. de Kernévez 29000 QUIMPER - FRANCE Tel: (+33) 2.98.55.68.95 Fax: (+33) 2.98.53.42.13
2. Company contact
Philippe VEISTROFFER, General Manager Tel: (+33) 2.98.55.68.95
3. Product
- Trade name: ARROW® anatomical porous glenoid
- Common name: Shoulder prosthesis
Classification:
Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis. Product code: MBF Regulation: 21 CFR 888.3670 Class: II
Shoulder joint metal/polymer non-constrained cemented prosthesis Product code: KWT Regulation: 21 CER 888.3650 Class: II
Shoulder joint metal/polymer semi-constrained cemented prosthesis Product code: KWS Regulation: 21 CFR 888.3660 Class: II
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4. Predicate/ Leqally marketed devices
The ARROW anatomical porous glenoid, is substantially equivalent to the following legally marketed devices:
| Manufacturer: | Fournitures Hospitalières Industrie |
|---|---|
| Device Trade Name: | ARROW Anatomical Shoulder System |
| 510 (K): | K093599 |
| Manufacturer: | Fournitures Hospitalières Industrie |
| Device Trade Name: | ARROW Reverse Shoulder System |
| 510 (K): | K112193 |
| Manufacturer: | |
| Device Trade Name: | |
| 510 (K): | Fournitures Hospitalières Industrie |
| ARROW Reverse Shoulder long keel and short keel glenoid base | |
| K142778 | |
| Manufacturer: | Biomet Orthopedics |
| Device Trade Name: | Bio-Modular Shoulder System |
| 510 (K): | K030710 |
5. Device description
The ARROW anatomical porous glenoid consists of a glenoid insert and a porous glenoid base. The porous glenoid base is used with bone screws for fixation (cleared in K112193). The glenoid inserts and the porous glenoid bases are used in total anatomical prosthesis and are designed to articulate with the ARROW anatomical shoulder system (cleared in K093599).
The ARROW anatomical 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 namely: simple humeral prosthesis, total anatomical prosthesis (cemented glenoid implant with 4 pegs), total anatomical prosthesis (porous glenoid implant), pending, and reverse prosthesis.
6. Indications for use / Intended use
- . Indications for use
TOTAL ANATOMICAL PROSTHESIS (POROUS GLENOID IMPLANT)
- Centred glenohumeral osteoarthritis ।
- -Rheumatoid polvarthritis
- -Post-traumatic sequela with glenoid injury
- Fractures of the proximal humerus with glenoid injury -
- -Revision for glenoid loosening
- -Glenoid bone loss, where bone graft is needed
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A functional rotator cuff is necessary to use this device
The porous glenoid base is intended for cementless application with the addition of bone screws for fixation.
The ARROW anatomical porous glenoid is a part of the full ARROW shoulder system, which includes other prosthesis configurations with other indications, as below:
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 -
- -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 -
- Fracture sequela, functional rotator cuff with glenoid iniury. -
REVERSE PROSTHESIS
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 metal-back glenoid baseplate is intended for cementless application with the addition of bone screws for fixation.
- . Intended use
All the implants of shoulder prosthesis are used for primary or revision surgeries.
The glenoid base is intended for cementless application with the addition of cortical or cancellous bone screws. The porous glenoid base must be used only for a total anatomical prosthesis.
7. Comparison of technological characteristics
The ARROW anatomical 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 materials (titanium alloy for the porous glenoid base and polyethylene for the glenoid insert),
- they are available in similar ranges of sizes, -
- they bear design features similarities.
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8. Performances
The ARROW anatomical porous glenoid was tested according to the ASTM F 1829 and ASTM F 2028 standards. After the tests were completed, it was determined that the ARROW anatomical 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 Regulations. Testing has been performed to establish product non-pyrogenicity.
9. 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 anatomical porous glenoid, as being substantially equivalent to the already cleared predicate devices selected to draw a comparison.
10. Conclusion
Following the examination of all the above mention, we believe that the ARROW anatomical porous glenoid is substantially equivalent to the selected predicate devices in terms of intended use, ranges of sizes, materials, performances, safety and effectiveness.