(496 days)
No
The summary describes a mechanical shoulder prosthesis and its components. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are focused on mechanical and material properties.
Yes
The device is a prosthesis designed to replace parts of the shoulder joint due to various conditions (e.g., osteoarthritis, necrosis, trauma), which falls under the definition of a therapeutic device as it is intended to treat a medical condition.
No
Explanation: The device is described as a "prosthese" (prosthesis), specifically a "humeral prosthesis" or "shoulder prosthesis," which is an implanted medical device used to replace a joint, not to diagnose a condition. The "intended use/indications for use" consistently describe situations where the prosthesis is to be implanted, not used for diagnostic purposes.
No
The device description explicitly states that the device is composed of physical components manufactured from medical grade titanium alloy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a prosthesis designed for surgical implantation to treat various shoulder conditions like osteoarthritis, rheumatoid arthritis, and post-traumatic sequelae. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details the physical components of a shoulder prosthesis (stems, metaphysis, diaphysis) and the materials used for their construction. This aligns with a medical implant, not a device used to test samples outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on mechanical testing, sterilization, packaging, and biocompatibility, which are relevant for implantable devices, not IVDs.
In summary, the device is a surgical implant used to replace or augment a damaged shoulder joint, which falls under the category of a medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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
- 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.
Product codes
PHX, HSD, KWS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, humeral, glenoid cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K112193, K093599, K150569, K162726, K190290, K060692, K080642, K021478
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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
1
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
2
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.
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.
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.
3
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4
510(k) Summary FH Industrie ARROW Short Stem Humeral System 29 November 2021
| Company: | FH INDUSTRIE
ZI DE KERNEVEZ-6 RUE NOBEL
QUIMPER Finistere, FRANCE 29000 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact: | Patricia DONNARD -- FH Industrie
Naoual 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 Uncemented
Shoulder Prosthesis, Reverse Configuration
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
| Classification: | Class II |
| Regulation Number: | 21 CFR 888.3690 (Shoulder joint humeral (hemi-shoulder) metallic
uncemented prosthesis)
21 CFR 888.3660 (Shoulder Prosthesis, Reverse Configuration) |
| Panel: | Orthopedic |
| Product Code: | PHX, HSD,KWS |
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.
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
5
- 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 and diaphyseal 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.
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)
6
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.