(28 days)
No
The document describes a system of surgical instruments for preparing anatomy during shoulder arthroplasty. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance study focuses on mechanical impact testing, not algorithmic performance.
No
The device is described as specialized instruments for preparing anatomy prior to implantation of shoulder system components, not for treating a disease or condition itself.
No
The device description clearly states its purpose is to "prepare anatomy prior to implantation" and to "provide an alternate approach in ensuring proper preparation of the glenoid bone and tissue." This indicates a surgical preparation function, not a diagnostic one.
No
The device description explicitly states it consists of "specialized instruments" and a "drop-in instrument tray," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states that the Augment Off-Axis Instrument System consists of "specialized instruments intended to prepare anatomy prior to implantation of Comprehensive® Reverse Shoulder System components... or Alliance® Augmented Glenoid System components..." These are surgical instruments used during a surgical procedure on the patient's body, not for testing samples outside the body.
- Intended Use: The intended use is to prepare the glenoid bone and tissue for receiving an implant, which is a surgical step.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, performing tests, or providing diagnostic information based on laboratory results.
Therefore, the Augment Off-Axis Instrument System is a surgical instrument system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Augment Off-Axis Instrument System consists of specialized instruments intended to prepare anatomy prior to implantation of Comprehensive® Reverse Shoulder System components in reverse total shoulder arthroplasty procedures or Alliance® Augmented Glenoid System components in anatomic total shoulder arthroplasty procedures in accordance with their respective cleared indications for use and contraindications.
The instruments for this system are specifically indicated for use with the Comprehensive ® Reverse Shoulder System (K193373) or the Alliance® Augmented Glenoid System (K193180).
Product codes
PHX, KWS, KWT
Device Description
The Augment Off-Axis Instrument System consists of specialized instruments that are designed for preparation of anatomy prior to implantation of Comprehensive® Reverse Shoulder System or Alliance® Augmented Glenoid System components. The instruments in this system are intended to provide an alternate approach in ensuring proper preparation of the glenoid bone and tissue for receipt of a glenoid implant augment in reverse and anatomic total shoulder arthroplasty procedures.
A drop-in instrument tray contains the Augment Off-Axis reusable surgical instruments for secure and ergonomic storage, sterilization, and transportation between uses.
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
Nonclinical: The impact of the modifications on the subject device's impact performance was evaluated via analysis of the worst-case device between the subject and predicate. Fix Surgical determined that the modification did not introduce a new worst-case scenario compared to the predicate device and no further mechanical testing was performed. The subject device can be adopted into the performance testing reports in K233148.
Clinical: Clinical testing was not required as a basis for substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
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
May 15, 2024
Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Fix Surgical % Jennifer Palinchik President Jalex Medical 27865 Clemens Road, Suite #3 Westlake, Ohio 44145
Re: K241043
Trade/Device Name: Augment Off-Axis Instrument System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: PHX, KWS, KWS, KWT Dated: April 16, 2024 Received: April 17, 2024
Dear Jennifer Palinchik:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,
Joseph P.
Russell -S
for: Farzana Sharmin, PhD
Assistant Director
DHT6A: Division of Joint Arthroplasty Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Digitally signed by Joseph P.
Russell -S
Date: 2024.05.15 17:08:14
-04'00'
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
Augment Off-Axis Instrument System
Indications for Use (Describe)
The Augment Off-Axis Instrument System consists of specialized instruments intended to prepare anatomy prior to implantation of Comprehensive® Reverse Shoulder System components in reverse total shoulder arthroplasty procedures or Alliance® Augmented Glenoid System components in anatomic total shoulder arthroplasty procedures in accordance with their respective cleared indications for use and contraindications.
The instruments for this system are specifically indicated for use with the Comprehensive ® Reverse Shoulder System (K193373) or the Alliance® Augmented Glenoid System (K193180).
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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3
Image /page/3/Picture/0 description: The image shows the logo for FIX SURGICAL. The logo consists of a circular icon on the left and the text "FIX SURGICAL" on the right. The icon contains a stylized letter "S" formed by two curved lines within a circle. The text "FIX SURGICAL" is in a sans-serif font, with "FIX" appearing larger than "SURGICAL". The color of the logo is a light blue.
Page 1 of 2 510(k) Submission -Augment Off-Axis Instrument System
510(k) Summary
| Applicant: | Fix Surgical
425 Fayette Street, #617
Conshohocken, PA 19428 |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Date: | 05/15/2024 |
| Applicant Contact: | Brian Karpinski, President
brian@fixsurgical.com |
| Contact Person:
Contact Email:
Contact Telephone:
Contact Fax: | Jennifer Palinchik, President
jpalinchik@jalexmedical.com
(440) 935-3282
(440) 933-7839 |
| Regulation Number: | 21 CFR §888.3660 |
| Classification Product Code: | PHX, KWS, KWT |
| Device Trade Name:
Device Classification Name: | Augment Off-Axis Instrument System
Shoulder joint metal/polymer semi-constrained cemented prosthesis |
| Device Common Name:
Device Class:
Reviewing Panel: | Shoulder Prosthesis
II
Orthopedic |
| Primary Predicate Device: | K233148 - Augment Off-Axis Instrument System |
Device Description:
The Augment Off-Axis Instrument System consists of specialized instruments that are designed for preparation of anatomy prior to implantation of Comprehensive® Reverse Shoulder System or Alliance® Augmented Glenoid System components. The instruments in this system are intended to provide an alternate approach in ensuring proper preparation of the glenoid bone and tissue for receipt of a glenoid implant augment in reverse and anatomic total shoulder arthroplasty procedures.
A drop-in instrument tray contains the Augment Off-Axis reusable surgical instruments for secure and ergonomic storage, sterilization, and transportation between uses.
4
Image /page/4/Picture/0 description: The image shows the logo for Fix Surgical. The logo consists of a circular icon on the left and the text "FIX SURGICAL" on the right. The icon contains a stylized letter "S" with a wave-like design inside a circle. The text "FIX SURGICAL" is in a sans-serif font and is colored in the same blue as the icon.
Page 2 of 2 510(k) Submission -Augment Off-Axis Instrument System
Indications for Use and Intended Use:
The Augment Off-Axis Instrument System consists of specialized instruments intended to prepare anatomy prior to implantation of Comprehensive® Reverse Shoulder System components in reverse total shoulder arthroplasty procedures or Alliance® Augmented Glenoid System components in anatomic total shoulder arthroplasty procedures in accordance with their respective cleared indications for use and contraindications.
The instruments for this system are specifically indicated for use with the Comprehensive ® Reverse Shoulder System (K193373) and Alliance® Augmented Glenoid System (K193180).
Description of Modifications:
The Augment Off-Axis Instrument System is an updated version of a legally marketed previous generation of the device. The purpose of this submission is for Fix Surgical to obtain clearance for design changes that include minor design modifications to the Comprehensive Off-Axis Inserter/Remover and minor edits to the labeling for clarification purposes. There were no changes to material or sterilization parameters.
Summary of Technological Characteristics:
Collectively, the instruments of the subject Augment Off-Axis Instrument System have the same intended use and indications for use as the predicate system. Technological characteristics of the subject system are similar to those of the predicate, and the information provided herein demonstrates that any differences do not impact safety or effectiveness.
These aspects of the subject device were determined to be substantially equivalent to the predicate device as the systems compare similarly in:
- . Regulatory Characteristics and Intended Use/Indications for Use
- Device Function/Performance
- Materials and Manufacturing Processes
- Design Features/Dimensions
- . Post-Processing Procedures, including Sterility and Shelf-Life Characteristics
Performance Data - Nonclinical:
The impact of the modifications on the subject device's impact performance was evaluated via analysis of the worst-case device between the subject and predicate. Fix Surgical determined that the modification did not introduce a new worst-case scenario compared to the predicate device and no further mechanical testing was performed. The subject device can be adopted into the performance testing reports in K233148.
Clinical Testing:
Clinical testing was not required as a basis for substantial equivalence.
Conclusion:
Based upon a comparison of indications for use, designs, materials and sterilization method, performance characteristics, and operational principles, the components of the Augment Off-Axis System are substantially equivalent to those of the predicate device identified in this premarket notification.