(174 days)
No
The document describes a medical device for shoulder replacement and does not mention any AI, machine learning, or deep neural network components. The performance studies focus on mechanical and material testing rather than AI model validation.
Yes
The device is a reverse total shoulder arthroplasty system, explicitly indicated for the relief of pain and significant disability due to gross rotator cuff deficiency, which aligns with the definition of a therapeutic device.
No
This device is a shoulder replacement system (an arthroplasty system) used for treatment, not for diagnosing conditions. Its purpose is to replace parts of the shoulder joint.
No
The device is a system for total shoulder arthroplasty, consisting of multiple physical components (glenoid baseplate, glenosphere, humeral stem, polymer bearing component, supporting instrument trays, and accessories). The performance studies section explicitly details non-clinical tests on these physical components (e.g., "Glenoid Baseplate Loosening," "Humeral Stem Fatigue"). These are all characteristics of a hardware medical device, not a software-only one.
No.
This device is a surgical implant (reverse total shoulder arthroplasty system) used to replace parts of the shoulder joint, which is an in-vivo application, not an in-vitro diagnostic test.
N/A
Intended Use / Indications for Use
The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The restor3d rTSA System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Glenoid component with porous surface is indicated for uncemented biological fixation application only. The restor3d rTSA System glenoid baseplate components are intended for cementless application with the addition of screw fixation.
Humeral components with porous surface are indicated for either cemented or uncemented applications.
Product codes
PHX, KWS
Device Description
The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws).
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
The subject restor3d Reverse Total Shoulder Arthroplasty System was subject to the following non-clinical performance tests to support the assertion of substantial equivalence:
- Glenoid Baseplate Loosening per ASTM F2028
- Glenoid Baseplate Fatigue and corrosion analysis
- Morse Taper Disassembly Strength per ASTM F2009
- Humeral Stem Fatigue and corrosion analysis
- Bone Screw Testing per ASTM F543
- Poly Liner Performance Tests per ASTM F1820
- Range of Motion Analysis per ASTM F1378
- Wear Analysis
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.”
FDA 510(k) Clearance Letter - restor3d Reverse Total Shoulder Arthroplasty System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 19, 2025
restor3d
Brianna Prindle
Director of Regulatory Affairs
4001 NC-54 Hwy
Suite 2160
Durham, North Carolina 27709
Re: K243643
Trade/Device Name: restor3d Reverse Total Shoulder Arthroplasty 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
Dated: April 18, 2025
Received: April 18, 2025
Dear Brianna Prindle:
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.
Page 2
K243643 - Brianna Prindle Page 2
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).
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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243643 - Brianna Prindle Page 3
assistance/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,
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 Farzana Sharmin -S
Date: 2025.05.19 16:43:03 -04'00'
Enclosure
Page 4
FORM FDA 3881 (6/20) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K243643
Device Name: restor3d reverse Total Shoulder Arthroplasty System
Indications for Use (Describe)
The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The restor3d rTSA System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Glenoid component with porous surface is indicated for uncemented biological fixation application only. The restor3d rTSA System glenoid baseplate components are intended for cementless application with the addition of screw fixation.
Humeral components with porous surface are indicated for either cemented or uncemented applications.
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)
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:
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"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."
Page 5
K243643
4001 NC-54 Hwy Suite 3160
Durham, NC 27709
984.888.0593
Traditional 510(k) Page 1 of 3
restor3d Reverse Total Shoulder Arthroplasty System
510(k) Summary
Date Prepared: May 19, 2024
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
A. 510(k) Owner:
restor3d, inc.
4001 NC-54 Hwy, Suite 3160
Durham, NC 27709
B. Primary Correspondent:
Brianna Prindle
Director of Regulatory Affairs
brianna@restor3d.com
C. Premarket Notification:
Submission Type: Traditional 510(k)
Trade Name: restor3d Reverse Total Shoulder Arthroplasty System
Classification Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis
Regulation Number: 888.3660
Product Code: PHX, KWS
Classification: II
Review Panel: Orthopedic
D. Indications for Use:
The restor3d rTSA System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The restor3d rTSA System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Glenoid component with porous surface is indicated for uncemented biological fixation application only. The restor3d rTSA System glenoid baseplate components are intended for cementless application with the addition of screw fixation.
Humeral components with porous surface are indicated for either cemented or uncemented applications.
Page 6
K243643
4001 NC-54 Hwy Suite 3160
Durham, NC 27709
984.888.0593
E. Predicate Devices:
The restor3d Reverse Total Shoulder Arthroplasty System is substantially equivalent to the following devices:
| 510(k) | Trade Name | Manufacturer |
|---|---|---|
| Primary Predicate Device | ||
| K193373 | Comprehensive® Reverse Shoulder | Zimmer Biomet |
| Reference Device | ||
| K240591 | ||
| K192778 | Kinos Axiom Total Ankle System | restor3d |
F. Device Description:
The restor3d Reverse Total Shoulder Arthroplasty System is intended for patients requiring a reverse shoulder replacement for patients with a functional deltoid muscle and with a deficient rotator cuff. The restor3d Reverse Total Shoulder Arthroplasty System consists of the glenoid baseplate, glenosphere intraoperatively affixed to the baseplate, humeral stem, and polymer bearing component affixed to the humeral stem. Additionally, the system includes supporting standard instrument trays and all required accessories (e.g., security screws, peripheral screws).
G. Comparison of Technological Characteristics
The restor3d Reverse Total Shoulder Arthroplasty System is substantially equivalent to the predicate device (Biomet, Comprehensive Reverse Shoulder, K193373) in intended use, indications for use and performance specifications. Additionally, the restor3d Reverse Total Shoulder Arthroplasty System utilizes similar materials and manufacturing processes as the reference device, the Kinos Axiom Total Ankle System (K240591). The subject and predicate device is comparable in terms of design characteristics; however, the subject rTSA system differs from the predicate in the manufacturing process, as the glenoid baseplate and humeral stems are additively manufactured with a porous surface.
H. Summary of Non-Clinical Testing
The subject restor3d Reverse Total Shoulder Arthroplasty System was subject to the following non-clinical performance tests to support the assertion of substantial equivalence:
- Glenoid Baseplate Loosening per ASTM F2028
- Glenoid Baseplate Fatigue and corrosion analysis
- Morse Taper Disassembly Strength per ASTM F2009
- Humeral Stem Fatigue and corrosion analysis
- Bone Screw Testing per ASTM F543
- Poly Liner Performance Tests per ASTM F1820
- Range of Motion Analysis per ASTM F1378
- Wear Analysis
Page 7
K243643
4001 NC-54 Hwy Suite 3160
Durham, NC 27709
984.888.0593
Traditional 510(k) Page 3 of 3
restor3d Reverse Total Shoulder Arthroplasty System
I. Conclusions:
In summary, the non-clinical bench testing demonstrates that the subject restor3d rTSA system is substantially equivalent to the predicate Zimmer Biomet Comprehensive Reverse Shoulder (K193373). The subject rTSA system does not raise any different questions of safety or effectiveness as compared to the predicate Zimmer Biomet Comprehensive Reverse Shoulder (K193373).