(126 days)
No
The summary describes a physical implant device made of PMMA and stainless steel, with a mechanical mode of action and antibiotic elution. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is a temporary shoulder replacement that provides mechanical function and delivers antibiotics to treat a septic process, thus serving a therapeutic purpose.
No
The device is a temporary shoulder spacer designed to manage septic processes in shoulder replacements and facilitate subsequent surgery, not to diagnose medical conditions.
No
The device description clearly states it is a physical implant made of polymethylmethacrylate (PMMA) with a stainless steel reinforcing structure. It is a hardware device.
Based on the provided information, the Remedy® Shoulder Spacer is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health, such as diagnosing a disease or monitoring a condition.
- Remedy® Shoulder Spacer Function: The Remedy® Shoulder Spacer is a physical implant designed to be surgically inserted into the shoulder joint. Its function is mechanical (providing support and range of motion) and therapeutic (delivering gentamicin locally to treat infection). It does not analyze biological specimens to provide diagnostic information.
The description clearly states its intended use is as a temporary implant for patients undergoing a two-stage shoulder replacement due to infection. This is a therapeutic and supportive function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Remedy® Shoulder Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total or hemi-shoulder replacement in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms.
The head and stem components are inserted into the glenoidal cavity and humeral medullary canal, respectively, following removal of the existing prosthetic components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The Remedy® Shoulder Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).
Product codes
KWS, MBB
Device Description
The Remedy® Shoulder Spacer is a sterile, single-use device intended for temporary use (maximum 180 days) as shoulder replacement.
The Remedy® Shoulder Spacer is composed of two components (a head and a stem) that are intended to be used together to form a temporary shoulder spacer; the components are available in a range of sizes.
The device is made of fully formed polymethylmethacrylate (PMMA), which is radioopaque and contains gentamicin. The stem component has also an inner stainless steel reinforcing structure.
The Remedy® Shoulder Spacer provides a functional-mechanical mode of action; it provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. It is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Shoulder joint, glenoidal cavity, humeral medullary canal
Indicated Patient Age Range
skeletally mature patients
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)
Sterilization and Shelf Life: The devices are sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of the devices has been established through stability studies.
Biocompatibility: Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible and suitable for their intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" have been taken into account to evaluate the biocompatibility of the device materials.
Performance Testing: Performance testing was performed to characterize the Remedy Shoulder Spacer. This testing included the evaluation of the static and fatigue performances, the surface roughness, the disassembling and the antibiotic (gentamicin) elution testing.
The performance data demonstrate that the new devices are substantially equivalent to the predicate device Tecres' Interspace Shoulder.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K131135, K042021, K061454, K140063, K040432, K071032, K103466, K062273, K062274, K112470
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 30, 2015
Osteoremedies LLC % Diane M. Horwitz, Ph.D., RAC Regulatory Affairs Consultant Mandell Horwitz Consultants, LLC 2995 Steven Martin Drive Fairfax, Virginia 22031
Re: K152267
Trade/Device Name: Remedy® Shoulder Spacer Regulation Number: 21 CFR 888.3660 Regulation Name: Shoulder joint metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: KWS, MBB Dated: November 17, 2015 Received: November 17, 2015
Dear Dr. Horwitz:
This letter corrects our substantially equivalent letter of December 15, 2015.
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
1
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 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" (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/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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152267
Device Name Remedy® Shoulder Spacer
Indications for Use (Describe)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
The Remedy® Shoulder Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total or hemi-shoulder replacement in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms.
The head and stem components are inserted into the glenoidal cavity and humeral medullary canal, respectively, following removal of the existing prosthetic components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The Remedy® Shoulder Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).
| 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.
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."
3
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
1 GENERAL INFORMATION
1.1 Submitter and Owner of the 510(k)
Osteoremedies LLC 6800 Poplar Avenue Suite 120 Memphis, TN 38138
1.2 Official Correspondent
Diane Mandell Horwitz, PhD, RAC Requlatory Affairs Consultants Mandell Horwitz Consultants, LLC 2995 Steven Martin Drive Fairfax, Virqinia 20031
Telephone: (703) 307-2921 Fax: (703) 242-1117 E-mail: dmh@mandellhorwitzconsulting.com
1.3 Devices Subject of this 510(k)
Remedy® Shoulder Spacer
1.4 Date of Preparation
October 25, 2015
2 NAME OF THE DEVICE AND CLASSIFICATION INFORMATION
2.1 Trade/Proprietary Name
Remedy® Shoulder Spacer, K152267
2.2 Common/Usual Name
Modular temporary shoulder prosthesis with gentamicin
2.3 Classification Information
| Classification Name: | Shoulder joint metal/polymer semi-constrained
cemented prosthesis |
|----------------------------|-------------------------------------------------------------------------|
| Classification Regulation: | 888.3660 |
| Regulatory Class: | II |
| Product Code: | KWS - prosthesis, shoulder, semi-constrained,
metal/polymer cemented |
| Panel: | Orthopedic |
4
Because the Remedy® Shoulder Spacers are made from antibiotic containing bone cement, they may also be classified as Class II medical device within the generic type of device known as:
Classification Name: Polymethylmethacrylate (PMMA) Bone Cement
Classification Requlation: 21 CFR § 888.3027
Regulatory Class: Class II
Product Code: MBB - Bone cement, antibiotic
Orthopedic Panel:
3 PREDICATE DEVICE
The predicate device is as follows:
-
Tecres' InterSpace Shoulder, which was cleared through 510(k) application K060535 and K112983.
The following reference devices were considered in analysis of the technological characteristics of the Remedy® Shoulder Spacer. -
. Reference devices for discussion of sizes and shapes: StageOne Shoulder Cement Spacer Molds (K131135), Equinoxe Shoulder System (K042021, K061454, K140063), Solar Total Shoulder System (K040432), and Univers II Total Shoulder System (K071032, K103466).
-
. Reference devices for evaluation of surface roughness: Tecres InterSpace Knee (K062273 and K062274) and OsteoRemedies Knee Modular Spacer (K112470).
4 DEVICE DESCRIPTION
The Remedy® Shoulder Spacer is a sterile, single-use device intended for temporary use (maximum 180 days) as shoulder replacement.
The Remedy® Shoulder Spacer is composed of two components (a head and a stem) that are intended to be used together to form a temporary shoulder spacer; the components are available in a range of sizes.
The device is made of fully formed polymethylmethacrylate (PMMA), which is radioopaque and contains gentamicin. The stem component has also an inner stainless steel reinforcing structure.
The Remedy® Shoulder Spacer provides a functional-mechanical mode of action; it provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. It is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure.
5
5 INDICATIONS FOR USE
Below is the indication for use.
The Remedy Shoulder Spacer, which consists of a modular head and stem, is indicated for temporary use (maximum 180 days) as an adjunct to total or hemishoulder replacement in skeletally mature patients undergoing a two-stage procedure due to a septic process and where gentamicin is the most appropriate antibiotic based on the susceptibility pattern of the infecting micro-organisms.
The head and stem components are inserted into the glenoidal cavity and humeral medullary canal, respectively, following removal of the existing prosthetic components and radical debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The Remedy® Shoulder Spacer is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.q. resection arthroplasty, fusion etc.).
6 COMPARISON OF THE INTENDED USE WITH THE PREDICATE DEVICE
The Remedy® Shoulder Spacer and the predicate device are intended to be used in the same surgical procedure (two-stage revision procedure) in the same target patient population, and provide the same primary function of providing patients a temporary shoulder implant to allow for a natural range of motion and partial weight bearing. Thus, the Remedy® Shoulder Spacer has the same intended use as the predicate device.
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Remedy® Shoulder Spacer share many similar technological characteristics compared to the predicate Tecres' Interspace Shoulder, including important considerations such as the same materials, and mechanical and chemical-physical performances. Both devices share the same tissue contact and duration of contact. Both are provided preformed to the user, sterile and for single-use. Nonetheless, there are differences in the design due to the modularity of the Remedy® Shoulder Spacer and the sizes of the devices. Indeed, the head and the stem components of the Remedy" Shoulder Spacer are provided separate in order to combine them at the time of use to achieve the final confiquration and fit better the patient's anatomy. The sizes of the components have been chosen in order to cover most of shoulder prostheses configurations currently available on the US market (see list of reference devices for variations in sizes and shapes of shoulder prostheses). These comparisons are summarized in Table 1 on the following page.
6
| Characteristics | OsteoRemedies LLC
Remedy® Shoulder Spacer | Tecres SpA
InterSpace Shoulder
K060535 and K112983 | Comparison |
|---------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------|
| Main
Components | Polymethylmethacrylate
(PMMA)
Methylmethacrylate (MMA)
Barium Sulphate | Polymethylmethacrylate
(PMMA)
Methylmethacrylate (MMA)
Barium Sulphate | Same |
| Other
components | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone | Same |
| Antibiotics | Gentamicin Sulphate | Gentamicin Sulphate | Same |
| Inner core | Stainless Steel (AISI 316 ESR) | Stainless Steel (AISI 316 ESR) | Same |
| Design
(shape) | Head + Stem (separated) | Head + Stem (monoblock) | Different |
| Modularity | 3 heads, 3 stems, offset
adjustment | None | Different |
| Head Size | Ø: 40 – 45 – 50 mm | Ø: 41 - 46 mm | Different |
| Stem Size | L: 101 mm Ø: 7 mm
L: 116 mm Ø: 10.5 mm
L: 131 mm Ø: 14 mm | L: 99 mm Ø: 7 mm
L: 125 mm Ø: 11 mm | Different |
| Stem-neck
angle | 130° | 130° | Same |
| X-ray visibility | Yes | Yes | Same |
| Single-use
device | Yes | Yes | Same |
| Provided
Sterile | Yes | Yes | Same |
| Spacer
Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same |
| Sterility
Assurance
Level (SAL) -
Powder | 10-6 | 10-6 | Same |
| Shelf Life | 5 years | 5 years | Same |
| Table 1: Comparison of the Technological Characteristics with the Predicate Device | |||
|---|---|---|---|
| -- | -- | ------------------------------------------------------------------------------------ | -- |
8 PERFORMANCE DATA
This 510(k) submission provided performance data to establish the substantial equivalence of the new line of shoulder spacers to the predicate device. The following is a summary of the performance data.
Sterilization and Shelf Life: The devices are sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of the devices has been established through stability studies.
Biocompatibility: Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible and suitable for their intended use. Both ISO 10993 and FDA Draft Guidance "Use of International Standard ISO 10993. Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" have been taken into account to evaluate the biocompatibility of the device materials.
7
Performance Testing: Performance testing was performed to characterize the
Remedy Shoulder Spacer. This testing included the evaluation of the static and fatigue performances, the surface roughness, the disassembling and the antibiotic (gentamicin) elution testing.
The performance data demonstrate that the new devices are substantially equivalent to the predicate device Tecres' Interspace Shoulder.