(126 days)
Not Found
No
The document describes a mechanical shoulder arthroplasty system and its components, materials, and testing. There is no mention of software, algorithms, AI, or ML.
Yes
The device is intended to alleviate pain and restore function in patients with painful and disabling joint disease of the shoulder, indicating a therapeutic purpose.
No
Explanation: The device is a surgical implant (shoulder arthroplasty system) intended to alleviate pain and restore function, not to diagnose a condition.
No
The device description clearly outlines physical components made of titanium, cobalt chrome, and polyethylene, intended for surgical implantation. This is a hardware medical device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "use in primary and revision total shoulder arthroplasty to alleviate pain and restore function." This describes a surgical implant used in vivo (within the body) for treatment, not a device used in vitro (outside the body) to diagnose a condition.
- Device Description: The description details the physical components of a shoulder implant (humeral stems, heads, glenoids) made from materials like titanium and cobalt chrome. These are materials used for surgical implants, not for diagnostic tests.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information. The device's function is mechanical replacement of a joint.
Therefore, this device is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: The Reunion® TSA System components are sterile, single-use devices intended for use in primary and revision total shoulder arthroplasty to alleviate pain and restore function. The subject humeral stems will be offered in both cementless applications. The self pressurizing glenoid components are intended for cemented use only.
Indications for Use:
For use as a Hemi or Total Shoulder Replacement:
- Aseptic necrosis of the humeral head .
- Painful, disabling joint disease of the shoulder resulting from: degenerative . arthritis, rheumatoid arthritis, or post-traumatic arthritis.
- Proximal humeral fractures and/or dislocation. .
- Clinical management problems where arthrodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other . procedure.
The gleonid components are intended for cemented use only.
The humeral stem components are intended for both cemented and cementless use.
Product codes (comma separated list FDA assigned to the subject device)
87KWS, 87HSD
Device Description
The subject Reunion® Total Shoulder Arthroplasty (TSA) System is intended for shoulder arthroplasty. The components of this system consist of humeral stems, a modular neck adapter, single radius heads, and self pressurizing glenoids (SPG). The humeral stem components will be manufactured from titanium allov according to ASTM F136 and will be offered in both cemented and cementless designs. The cementless humeral stem design will feature a circumferential plasma spray and hydroxyapatite (HA) coating and be offered in 7mm-17mm distal diameters in 1mm increments. The cemented humeral stems will be offered in 6mm-15mm distal diameters in 1mm increments and will also include 4 longer stems with distal diameters 6mm-12mm in 2 mm increments. These humeral stems were designed to mate with the subject single radius heads or the modular neck adapter, manufactured from cobalt chrome according to ASTM F1537, for compatibility with other marketed humeral heads. The single radius heads will be manufactured from cobalt chrome according to ASTM F75 and will be offered in spherical diameter head sizes 40mm-56mm in 4mm increments for both standard and eccentric designs. The self pressuring glenoids (SPG) will be manufactured from X3% polyethylene according to ASTM F648 and will mate with the single radius heads. The SPGs will be offered in both pegged and keeled configurations ranging from 40mm-56mm spherical diameters in 4mm increments.
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)
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The following mechanical tests were conducted according to ASTM F2028-08: Fatigue strength on humeral components and dynamic evaluation of glenoid loosening on the glenoids. The testing demonstrated that the ReUnion® TSA system components met performance requirements and are as safe and effective as their 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.
K955731, K062113, K950521, K962082, K001419, K990598, K992065, K052472, K060988
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
§ 888.3660 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 a handwritten string of characters. The string appears to be "K103835". The characters are written in a cursive style, with some connections between the letters and numbers. The image is in black and white.
510(k) Summary (
| Sponser: | Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430 |
|----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Avital Merl-Margulies
Regulatory Affairs Specialist
Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah, NJ 07430
Phone: (201) 831-6365 Fax: (201) 831-3365 |
| Date Prepared: | May 3, 2011 |
| Proprietary Name: | ReUnion® Total Shoulder Arthroplasty (TSA) System |
| Common Name: | Artificial Shoulder Components |
| Classification Name | 21 CFR §888.3660: Shoulder Joint Metal/Polymer Semi
Constrained Cemented Prosthesis
21 CFR §888.3690: Shoulder Joint Humeral (hemi-
shoulder) metallic uncemented prosthesis |
| Proposed Regulatory Class: | Class II |
| Product Codes: | 87KWS: Prosthesis, shoulder, semi-constrained,
metal/polymer, uncemented
87HSD: Prosthesis, shoulder, hemi-humeral, metallic,
cemented |
| Legally marketed device to which substantial equivalence is claimed: | |
| | Osteonics Shoulder Humeral Components: K955731 |
| | Solar ReUnion Fracture Stem: K062113 |
| | Osteonics All Polyethylene Glenoid Shoulder Component: K950521 |
| | Osteonics All Polyethylene Glenoid Shoulder Component: K962082 |
| | Solar Shoulder Offset Humeral Head: K001419 |
| | Osteonics Solar Shoulder Humeral Bearing Head: K990598 |
| | Depuy Global Advantage Shoulder, Global Advantage Humeral Stem, Global Advantage
Eccentric Head: K992065 |
| | Depuy Global Shoulder Crosslinked Glenoid: K052472 |
| | DVO Extremity Solutions Total and Hemi Shoulder System: K060988 |
Device Description:
The subject Reunion® Total Shoulder Arthroplasty (TSA) System is intended for shoulder arthroplasty. The components of this system consist of humeral stems, a
Page 1 of 3
1
K103835
modular neck adapter, single radius heads, and self pressurizing glenoids (SPG). The humeral stem components will be manufactured from titanium allov according to ASTM F136 and will be offered in both cemented and cementless designs. The cementless humeral stem design will feature a circumferential plasma spray and hydroxyapatite (HA) coating and be offered in 7mm-17mm distal diameters in 1mm increments. The cemented humeral stems will be offered in 6mm-15mm distal diameters in 1mm increments and will also include 4 longer stems with distal diameters 6mm-12mm in 2 mm increments. These humeral stems were designed to mate with the subject single radius heads or the modular neck adapter, manufactured from cobalt chrome according to ASTM F1537, for compatibility with other marketed humeral heads. The single radius heads will be manufactured from cobalt chrome according to ASTM F75 and will be offered in spherical diameter head sizes 40mm-56mm in 4mm increments for both standard and eccentric designs. The self pressuring glenoids (SPG) will be manufactured from X3% polyethylene according to ASTM F648 and will mate with the single radius heads. The SPGs will be offered in both pegged and keeled configurations ranging from 40mm-56mm spherical diameters in 4mm increments.
Intended Use:
The Reunion® TSA System components are sterile, single-use devices intended for use in primary and revision total shoulder arthroplasty to alleviate pain and restore function. The subject humeral stems will be offered in both cementless applications. The self pressurizing glenoid components are intended for cemented use only.
Indications for Use:
For use as a Hemi or Total Shoulder Replacement:
- Aseptic necrosis of the humeral head .
- Painful, disabling joint disease of the shoulder resulting from: degenerative . arthritis, rheumatoid arthritis, or post-traumatic arthritis.
- Proximal humeral fractures and/or dislocation. .
- Clinical management problems where arthodesis or alternative reconstructive . techniques are less likely to achieve satisfactory results.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other . procedure.
The gleonid components are intended for cemented use only.
Summary of Technologies:
The technological characteristics (material, design, sizes, and operational principles) of the ReUnion® TSA System components are similar or identical to its predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The following mechanical tests were conducted according to ASTM F2028-08: Fatigue strength on humeral components and dynamic evaluation of glenoid loosening on the glenoids. The testing demonstrated that the ReUnion® TSA
Image /page/1/Picture/15 description: The image shows the text "Page 2 of 3" written in cursive. The text indicates that it is the second page of a three-page document. The handwriting is somewhat stylized, with distinct loops and curves forming the letters. The overall impression is that of a handwritten note or document page number.
2
Image /page/2/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K1D3835". The characters are written in a cursive style, with some connections between the letters and numbers.
system components met performance requirements and are as safe and effective as their predicate devices.
Clinical Testing:
None provided as a basis for substantial equivalence
Conclusion
The ReUnion® TSA System is substantially equivalent to the predicate devices identified in this premarket notification.
Page 363
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Howmedica Osteonics Corp. % Ms. Avital Merl-Margulies Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430
MAY - 5 2011
Re: K103835
Trade/Device Name: ReUnion® Total Shoulder Arthroplasty (TSA) System Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, HSD Dated: April 29, 2011 Received: May 2, 2011
Dear Ms. Merl-Margulies:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
Page 2 - Ms. Avital Merl-Margulies
forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Reportal?roblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Aig B. R h
Mark N. Melker Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K103835
Device Name: ReUnion® Total Shoulder Arthroplasty (TSA) System
For use as a Henii of Total Shoulder Replacement:
- Aseptic necrosis of the humeral head o
- Painful, disabling joint disease;of the shoulder resulting from: degenerative arthritis, o rheumatoid arthritis, or post-traumatic arthritis.
- Proximal humeral fractures and/or dislocation. o
- Clinical management problems where arthrodesis or alternative reconstructive techniques o are less likely to achieve satisfactory results.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other o procedure.
The gleonid components are intended for cemented use only. The humeral stem components are intended for both cemented and cementless use.
| Prescription Use
| (Part 21 CFR 801, Subpart D) | X |
|---|---|
| AND/OR | Over-The-Counter Use |
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Page 1 of 1 | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|---|
| (Division Sign-Off) | |
| Division of Surgical, Orthopedic, and Restorative Devices | |
| 510(k) Number | K103835 |