(90 days)
Not Found
No
The document describes a physical medical device (cement spacer molds) and its mechanical and biological testing, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a temporary hemi-hip replacement used in a two-stage revision procedure due to a septic process, which directly addresses a medical condition (infection).
No
Explanation: The device is used to mold a temporary hemi-hip replacement in patients undergoing a two-stage revision due to a septic process. It is a therapeutic device, not one that identifies or diagnoses a condition.
No
The device description clearly states it is a physical product: "Disposable cement spacer molds with titanium reinforcement stem and prolongation". It is used to mold a temporary physical prosthesis.
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, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that this device is used to mold a temporary hemi-hip replacement which is then inserted into the body. This is a surgical implant/prosthesis, not a device used for testing samples outside the body.
- Intended Use: The intended use is to provide a temporary hip replacement during a two-stage revision procedure due to infection. This is a therapeutic intervention, not a diagnostic test.
Therefore, this device falls under the category of a surgical implant or prosthesis, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Disposable cement spacer molds with titanium reinforcement stem and prolongation are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-hip prosthesis made from the SpaceFlex Hip disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatmy performed (e.g. resection arthroplasty, fusion, etc.).
Due to the inherent mechanical limitations of the hemi-hip prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
Product codes
MBB, KWL, KWY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
femoral medullary canal and acetabular cavity
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
The mechanical properties of the SpaceFlex Hip System were tested in accordance with applicable international standards. In all instances the device functioned as intended and all results were satisfactory and met all performance specifications. The testing performed includes,
- Fatigue Test
- Gentamicin Elution Test
- Molding Temperature Analysis
Pyrogen testing was done in accordance with USP 38: NF33 "Medical Devices – Bacterial Endotoxins and Pyrogen Tests". The bacterial endotoxins verification tests concluded that the subject device and packaging is non-pyrogenic.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
G21 S.r.l % Barry Sands President ROMIS. Inc. 110 Haverhill Road, Suite #526 Amesbury, Massachusetts 01860
Re: K192041
Trade/Device Name: G21 SpaceFlex Hip Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: MBB, KWL, KWY Dated: July 25, 2019 Received: July 31, 2019
Dear Mr. Sands:
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. 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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
Laurence D. Coyne, Ph.D. Acting Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192041
Device Name G21 SpaceFlex Hip
Indications for Use (Describe)
Disposable cement spacer molds with titanium reinforcement stem and prolongation are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement.
The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection). The hemi-hip prosthesis made from the SpaceFlex Hip disposable cement molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatmy performed (e.g. resection arthroplasty, fusion, etc.).
Due to the inherent mechanical limitations of the hemi-hip prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
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
G21 S.r.l. 's SpaceFlex Hip K192041
SUBMITTER l.
G21 S.r.l. Via S. Pertini, 8 41039 S. Possidonio (MO) Italy
Phone: +39 0535 30312 Fax: +39 0535 417332
Contact Person: Manjusha Bharadwaj RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913 Phone: 1-(978) 358-7307 Fax: 1 (978) 477-0206
Date Prepared: 05 April 2019
II. DEVICE
| Trade/Device Name: | SpaceFlex Hip |
|---|---|
| Common or Usual Name: | Bone Cement Spacer Molds for Temporary Hip Replacement |
| Classification Name: | Bone cement, antibiotic |
| Regulation Number: | 21 CFR 888.3027, 21 CFR 888.3360, 21 CFR 888.3390 |
| Regulatory Class: | Class II |
| Product codes: | MBB, KWL, KWY |
lll. PREDICATE DEVICES
Primary Predicate: StageOne Select Hip Cement Spacer Molds, Biomet, Inc. (K161166)
Additional Predicate: SPACER-G Temporary Hip Prosthesis, Tecres S.p.A. (K031841)
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IV. DEVICE DESCRIPTION
Indications for Use / Intended Use:
Disposable cement spacer molds with titanium reinforcement stem and prolongation are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using low viscosity polymethylmethacrylate bone cement and inserted into the femoral medullary canal and acetabular cavity following removal of the existing femoral and acetabular implants and debridement.
The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). The hemi-hip prosthesis made from the SpaceFlex Hip disposable cement molds is not intended for use more than 180 days, at which time it must be explanted, and permanent devices implanted, or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).
Due to the inherent mechanical limitations of the hemi-hip prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.
V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological features of the SpaceFlex Hip are similar to the predicates with one difference in the sterilization method. The subject device has the same design, intended use and mode of operation as the predicate and the differences do not lead to new safety or effectiveness issues.
VI. PERFORMANCE DATA
The mechanical properties of the SpaceFlex Hip System were tested in accordance with applicable international standards. In all instances the device functioned as intended and all results were satisfactory and met all performance specifications. The testing performed includes,
-
- Fatigue Test
-
- Gentamicin Elution Test
-
- Molding Temperature Analysis
Pyrogen testing was done in accordance with USP 38: NF33 "Medical Devices – Bacterial Endotoxins and Pyrogen Tests". The bacterial endotoxins verification tests concluded that the subject device and packaging is non-pyrogenic.
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VII. CONCLUSION
The SpaceFlex Hip disposable cement spacer is substantially equivalent to other legally marketed cement spacers indicated for use to mold a temporary total hip replacement. The SpaceFlex Hip has the same general intended use and substantially the same indications for use, technological characteristics, and principles of operation as the previously cleared primary predicate, Biomet Inc.'s StageOne Select Hip Cement Spacer Molds (K161166) and additional predicate, Tecres S.p.A.'s SPACER-G Temporary Hip Prosthesis (K031841).
The substantial equivalence discussion included in the submission demonstrates the substantial equivalence of the SpaceFlex Hip System (the subject device) and its predicate devices as well as describing the minor differences in the technological characteristics, which do not raise any new questions of safety or efficacy. The performance testing - mechanical/bench testing - as well as the same indications for use demonstrate that the SpaceFlex Hip system is as safe and effective as its predicate devices.