(55 days)
Not Found
No
The description focuses on the material composition, mechanical function, and antibiotic elution properties of a temporary hip spacer device. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is a temporary implant used as an adjunct to total hip replacement in cases of septic processes, and it contains gentamicin to prevent bacterial adhesion, indicating a therapeutic function.
No
Explanation: The device is an acetabular cup designed for temporary use as an adjunct to total hip replacement in a specific medical context (septic process). It is an orthopedic implant, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a physical implant made of polymethylmethacrylate (PMMA) and contains gentamicin. It is a temporary joint replacement device.
Based on the provided information, the REMEDY® Acetabular Cup 46mm ID/54mm OD 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 for diagnosis, monitoring, or screening.
- REMEDY® Acetabular Cup Function: The REMEDY® Acetabular Cup is a temporary implantable device used within the body during a surgical procedure. Its function is mechanical (providing temporary joint support and range of motion) and therapeutic (delivering gentamicin locally to help treat infection). It does not analyze biological specimens in vitro.
The description clearly states its use as an adjunct to total hip replacement and its placement into the acetabular cavity. This is an in vivo application, not an in vitro one.
N/A
Intended Use / Indications for Use
The REMEDY® Acetabular Cup 46mm ID/54mm OD consists of an acetabular cup that is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) 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-organism(s).
The REMEDY® Acetabular Cup 46mm ID/54mm OD is positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The device must be combined with REMEDY® Hip Spacer using REMEDY® Modular Head 46 mm. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The REMEDY® Acetabular Cup 46mm ID/54mm OD 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, etc.).
Product codes (comma separated list FDA assigned to the subject device)
KWL, KWY, KWZ
Device Description
The Remedy® Acetabular Cup is a temporary spacer device available in a single size, intended to be combined with Remedy Hip Spacer using Remedy® Modular Head 46 mm.
The Remedy® Acetabular Cup is sterile, single-use device intended for temporary use (maximum 180 days) as joint replacement. The device is made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque and contains gentamicin. The mass used to fill the molds (the unformed PMMA resin) is prepared from powder and liguid components. The liquid component consists of methylmethacrylate (MMA), N, N dimethylp-toluidine and hydroquinone; the powder component consists of PMMA, barium sulphate, benzoyl peroxide and gentamicin sulphate.
The Remedy® Hip Spacer and Acetabular Cup provide a functional-mechanical mode of action; the system provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. The system is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure. The Remedy® Acetabular Cup is protected from bacterial adhesion due to the presence of gentamicin, similar to other spacers devices made from antibiotic loaded PMMA currently on the US market.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Acetabular cavity (hip)
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)
Performance Testing: Performance testing was performed to characterize the Remedy Acetabular Cup. This testing included the evaluation of the static and fatigue performances, the surface roughness, the device wear and the antibiotic (gentamicin) elution testing.
The performance data demonstrate that the new device is substantially equivalent to the predicate device.
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.
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
§ 888.3360 Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis.
(a)
Identification. A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (§ 888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right is the logo for the U.S. Food & Drug Administration (FDA). The FDA logo includes the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written below in a smaller font.
February 22, 2018
OsteoRemedies LLC % Diane Mandell Horwitz, Ph.D., RAC Regulatory Affairs Consultant Mandell Horwitz Consultants LLC 2995 Steven Martin Drive Fairfax, Virginia 20031
Re: K173967
Trade/Device Name: Remedy® Acetabular Cup Regulation Number: 21 CFR 888.3360 Regulation Name: Hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis Regulatory Class: Class II Product Code: KWL, KWY, KWZ Dated: December 28, 2017 Received: December 29, 2017
Dear Dr. Horwitz:
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 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);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Katherine D. Kavlock -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K173967
Device Name Remedy® Acetabular Cup
Indications for Use (Describe)
The REMEDY® Acetabular Cup 46mm ID/54mm OD consists of an acetabular cup that is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) 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-organism(s).
The REMEDY® Acetabular Cup 46mm OD is positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The device must be combined with REMEDY® Hip Spacer using REMEDY® Modular Head 46 mm. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The REMEDY® Acetabular Cup 46mm ID/54mm OD 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, etc.).
| 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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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
GENERAL INFORMATION 1
Submitter and Owner of the 510(k) 1.1
OsteoRemedies LLC 6800 Poplar Avenue Suite 120 Memphis, TN 38138
1.2 Official Correspondent
Diane Mandell Horwitz, PhD, RAC Regulatory Affairs Consultant Mandell Horwitz Consultants, LLC 2995 Steven Martin Drive Fairfax, Virginia 20031
Telephone: (703) 307-2921 E-mail: dmh@mandellhorwitzconsulting.com
1.3 510(k) Number and Devices Subject of this 510(k)
K173967 Remedy® Acetabular Cup
Date of Preparation 1.4
February 4, 2018
NAME OF THE DEVICE AND CLASSIFICATION INFORMATION 2
2.1 Trade/Proprietary Name
Remedy® Acetabular Cup
2.2 Common/Usual Name
Temporary Acetabular Cup Spacer with Gentamicin
2.3 Classification Information
| Classification Name: | Hip joint femoral (hemi-hip) metallic
cemented or uncemented prosthesis | Hip joint metal/polymer constrained cemented or
uncemented prosthesis |
| ---------------------- | ---------------------------------------------------------------------------- | -------------------------------------------------------------------------- |
|---|
4
| Classification Regulation: | 888.3360 | 888.3310 |
|---|---|---|
| Class: | II | II |
| Product Code(s): | KWL - Prosthesis, Hip, Hemi-, | |
| Femoral, Metal | ||
| KWY - Prosthesis, Hip, Hemi-, | ||
| Femoral, Metal/polymer, Cemented or | ||
| Uncemented | KWZ – Prosthesis, Hip, | |
| Constrained or Uncemented, | ||
| Metal/Polymer | ||
| Panel: | Orthopaedic | Orthopaedic |
ತೆ PREDICATE DEVICE
The predicate device is as follows:
- Remedy® Hip Spacer which was cleared originally through 510(k) application K112470.
DEVICE DESCRIPTION ব
The Remedy® Acetabular Cup is a temporary spacer device available in a single size, intended to be combined with Remedy Hip Spacer using Remedy® Modular Head 46 mm.
The Remedy® Acetabular Cup is sterile, single-use device intended for temporary use (maximum 180 days) as joint replacement. The device is made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque and contains gentamicin. The mass used to fill the molds (the unformed PMMA resin) is prepared from powder and liguid components. The liquid component consists of methylmethacrylate (MMA), N, N dimethylp-toluidine and hydroquinone; the powder component consists of PMMA, barium sulphate, benzoyl peroxide and gentamicin sulphate.
The Remedy® Hip Spacer and Acetabular Cup provide a functional-mechanical mode of action; the system provides patients a temporary implant allowing for a natural range of motion and partial weight-bearing during treatment. The system is designed to preserve soft tissue to prevent further complications, such as muscular contraction, and to facilitate the subsequent joint replacement procedure. The Remedy® Acetabular Cup is protected from bacterial adhesion due to the presence of gentamicin, similar to other spacers devices made from antibiotic loaded PMMA currently on the US market.
5 INDICATIONS FOR USE
Below is the indication for use.
The REMEDY® Acetabular Cup 46mm ID/54mm OD consists of an acetabular cup that is indicated for temporary use (maximum 180 days) as an adjunct to total hip replacement (THR) 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-organism(s).
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The REMEDY® Acetabular Cup 46mm ID/54mm OD is positioned into the acetabular cavity following removal of the existing acetabular and femoral components and radical debridement. The device must be combined with REMEDY® Hip Spacer using REMEDY® Modular Head 46 mm. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).
The REMEDY® Acetabular Cup 46mm ID/54mm OD 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, etc.).
6 COMPARISON OF THE INTENDED USE WITH THE PREDICATE DEVICE
The Remedy® Acetabular Cup 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 hip implant to allow for a natural range of motion and partial weight bearing. Thus, the Remedy® Acetabular Cup has the same intended use as the predicate device.
COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE 7 PREDICATE DEVICE
The Remedy® Acetabular Cup shares many of the same technological characteristics compared to the predicate Remedy® Hip Spacer, including important considerations such as the same materials, same PMMA bone cement formulation including antibiotic concentration, and mechanical performances. The technological characteristics are the same between the proposed device and the predicate device (see table).
| Ally Unuvi | ||||
|---|---|---|---|---|
| Characteristics | OsteoRemedies LLC | |||
| Remedy® Acetabular Cup – | ||||
| Subject Device | OsteoRemedies LLC | |||
| Remedy® Hip Spacer – | ||||
| Predicate Device (K112470) | Comparison | |||
| Main Material | ||||
| Components | Polymethylmethacrylate | |||
| (PMMA) | ||||
| Methylmethacrylate (MMA) | ||||
| Barium Sulphate | Polymethylmethacrylate | |||
| (PMMA) | ||||
| Methylmethacrylate (MMA) | ||||
| Barium Sulphate | Same | |||
| Other Material | ||||
| Components | Benzoyl peroxide | |||
| N,N-Dimethyl-p-toluidine | ||||
| Hydroquinone | Benzoyl peroxide | |||
| N,N-Dimethyl-p-toluidine | ||||
| Hydroquinone | Same | |||
| Antibiotic | Gentamicin Sulphate | Gentamicin Sulphate | Same | |
| Inner core | None | Stainless Steel (AISI 316 ESR) | Different | |
| Design (shape) | Cup | Head + Stem | Different | |
| Modularity and | ||||
| Sizes | None - 1 size for cup to match | |||
| 46 mm head | 3 heads, 3 stems, offset | |||
| adjustment | Different | |||
| Articulating | ||||
| Surfaces | PMMA (Remedy acetabular cup) | |||
| PMMA (Remedy hip spacer) | Patient Bone - PMMA (Remedy | |||
| hip spacer) | Different | |||
| X-ray Visibility | Yes | Yes | Same |
| Table 1: Summary of Technological Characteristics between the Remedy® Acetabula |
|---|
| Cup and the Predicate Device, the Remedy® Hip Spacer |
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| Characteristics | OsteoRemedies LLC
Remedy® Acetabular Cup –
Subject Device | OsteoRemedies LLC
Remedy® Hip Spacer –
Predicate Device (K112470) | Comparison |
|------------------------------------|-----------------------------------------------------------------|-------------------------------------------------------------------------|------------|
| Single-use Device | Yes | Yes | Same |
| Provided Sterile | Yes | Yes | Same |
| Spacer Sterilization
Method | Ethylene Oxide | Ethylene Oxide | Same |
| Sterility Assurance
Level (SAL) | 10-6 | 10-6 | Same |
| Shelf Life | 5 years | 5 years | Same |
The Remedy® Acetabular Cup and the predicate device, the Remedy® Hip Spacer, are intended to be used together to form a total hip implant: this is analogous to the Prostalac Hip System by DePuy Orthopedics, which served as a reference device for this design feature. Both provide total hip temporary spacers with antibiotic-loaded PMMA cement.
8 PERFORMANCE DATA
This 510(k) notification provided performance data to establish the substantial equivalence of the Remedy® Acetabular Cup 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. The device is tested for endotoxins using the LAL test (gel clot) in conformance with the EP current edition of the test and must meet