(184 days)
No
The description focuses on the physical components and material properties of a disposable cement mold for a temporary shoulder prosthesis. There is no mention of software, algorithms, data processing, or any terms related to AI or ML.
Yes
The device is used to mold a temporary prosthesis inserted into the shoulder following removal of implants due to a septic process, and it is used in conjunction with systemic antibiotic therapy. While primarily for space maintenance and antibiotic delivery, it directly addresses a medical condition (septic process) as part of a treatment plan.
No
The device is a temporary shoulder replacement used in a two-stage revision procedure due to a septic process, not for diagnosing a condition.
No
The device description explicitly states it is composed of "Disposable cement spacer molds with metal reinforcement stem," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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.
- Device Function: This device is a mold used to create a temporary implant (a hemi-shoulder replacement) that is surgically inserted into the patient's body. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes a surgical procedure involving the removal of existing implants and the insertion of a temporary prosthesis. This is a treatment, not a diagnostic process.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens from the patient.
Therefore, this device falls under the category of a surgical implant or a device used in a surgical procedure, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder 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 humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.
The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the SpaceFlex Shoulder 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-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitation throughout the implant period.
The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.
For what concerns the modes of usage of the bone cement potentially loaded with antibiotics, see the instructions for use of the selected bone cement.
Product codes (comma separated list FDA assigned to the subject device)
MBB, HSD, KWS
Device Description
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder 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 humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.
The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the SpaceFlex Shoulder 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, tusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitation throughout the implant period.
The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.
For what concerns the modes of usage of the bone cement potentially loaded with antibiotics, see the instructions for use of the selected bone cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humeral medullary canal and glenoid cavity of the shoulder
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
competent healthcare personnel
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)
The mechanical properties of the SpaceFlex Shoulder were tested in accordance with applicable international standards. The testing performed includes:
- Fatigue Test
- Visual Inspection and Dimensional Characterization Test
- Usability Test
- Gentamicin Elution Test
In all instances the device functioned as intended and all results were satisfactory and met all performance specifications. Performance testing showed equivalent performance to the K112983 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.
Interspace Temporary Shoulder Spacer with Gentamicin (K112983), StageOne Disposable Cement Spacer molds for making temporary Hemi-Shoulder prosthesis (K160071)
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.
Spaceflex Hip (K192041)
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
§ 888.3027 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.”
0
February 17, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
G21 S.r.l. % Barry Sands President and Founder RQMIS, Inc. 110 Haverhill Road, Suite 524 Amesbury, Massachusetts 01913
Re: K202338
Trade/Device Name: SpaceFlex Shoulder Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: MBB, HSD, KWS Dated: November 13, 2020 Received: November 19, 2020
Dear Barry 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,
for
Laura C. Rose, Ph.D. Assistant 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
2
Indications for Use
510(k) Number (if known) K202338
Device Name SpaceFlex Shoulder
Indications for Use (Describe)
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemishoulder 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 humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.
The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the SpaceFlex Shoulder 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-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patiently follow activity limitation throughout the implant period.
The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.
For what concerns the modes of the bone cement potentially loaded with antibiotics, see the instructions for use of the selected bone cement.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Research Use (Part 21 CFR 601 Subpart D) | Compassionate Use (21 CFR 601 Subpart E) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) SUMMARY
G21 S.r.l. 's SpaceFlex Shoulder 510k Submission
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: Barry Sands RQMIS, Inc. 110 Haverhill Road, Suite 524 Amesbury, MA 01913 Phone: 1-(978) 358-7307 Fax: 1 (978) 477-0206
Date Prepared: 22 July 2020
II. DEVICE
| Trade/Device Name: | SpaceFlex Shoulder |
|---|---|
| Common or Usual Name: | Temporary Shoulder Prosthesis |
| Classification Name: | Polymethylmethacrylate (PMMA) bone cement, antibiotic |
| shoulder joint humeral polymer/metal/polymer semi-constrained | |
| cemented prosthesis | |
| Regulation Number: | 21 CFR 888.3027 |
| Regulatory Class: | Class II |
| Product codes | MBB, KWS |
III. PREDICATE DEVICES
| Predicate Device: | Interspace Temporary Shoulder Spacer with Gentamicin
(K112983)
StageOne Disposable Cement Spacer molds for making temporary
Hemi-Shoulder prosthesis (K160071) |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reference Devices: | Spaceflex Hip (K192041) |
5
IV. DEVICE DESCRIPTION
Indications for Use / Intended Use:
Disposable cement spacer molds with metal reinforcement stem are indicated for use to mold a temporary hemi- shoulder 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 humeral medullary canal and glenoid cavity of the shoulder following removal of the existing humeral and glenoideal cavity implants and debridement. SpaceFlex Shoulder should only be used with G3A low-viscosity bone cement.
The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection).
The hemi-shoulder prosthesis made from the SpaceFlex Shoulder 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, tusion, etc.).
Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (low viscosity polymethylmethacrylate), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitation throughout the implant period.
The device can exclusively be used by competent healthcare personnel who has complete scientific and anatomical knowledge.
For what concerns the modes of usage of the bone cement potentially loaded with antibiotics, see the instructions for use of the selected bone cement.
V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The SpaceFlex Shoulder and its predicate, Interspace Temporary Shoulder Spacer with Gentamicin, have the same intended use and indications for use, technological characteristics and principle of operation. The differences between the molds in the subject and the predicate device do not raise any significant new risks. Through performance and mechanical testing and material information it has been established that these differences do not present any new issues of safety or effectiveness
VI. PERFORMANCE DATA
The mechanical properties of the SpaceFlex Shoulder 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,
6
-
- Fatigue Test
-
- Visual Inspection and Dimensional Characterization Test
-
- Usability Test
-
- Gentamicin Elution Test
Performance testing showed equivalent performance to the K112983 predicate device.
VII. CONCLUSION
The SpaceFlex Shoulder disposable cement spacer is substantially equivalent to other legally marketed cement spacers indicated for use to mold a temporary total shoulder replacement. The SpaceFlex Shoulder has the same general intended use and substantially the same indications for use, technological characteristics, and principles of operation as the previously cleared predicate, Interspace Temporary Shoulder Spacer with Gentamicin (K112983) and additional predicate device, StageOne Disposable Cement Spacer molds for making temporary Hemi-Shoulder prosthesis (K160071).
The substantial equivalence discussion included in the submission demonstrates the substantial equivalence of the SpaceFlex Shoulder 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 Shoulder system is as safe and effective as its predicate devices.