(337 days)
Not Found
No
The document describes a mechanical implant system for hip replacement and does not mention any software, algorithms, or data processing related to AI/ML.
Yes
The device is indicated for use in total hip arthroplasty to reduce or relieve pain and improve hip function for various conditions, which are therapeutic goals.
No
The device is an orthopedic implant (total hip arthroplasty system) used for treatment and pain relief, not for diagnosing a medical condition.
No
The device description clearly outlines physical components made of titanium alloy, CoCrMo, and UHMWPE, which are hardware materials. The testing described also focuses on mechanical properties of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for total hip arthroplasty to address conditions like osteoarthritis, rheumatoid arthritis, and fractures. This is a therapeutic intervention performed on the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as an acetabular system composed of physical components like shells, liners, and femoral heads, designed to be implanted in the hip joint. This is consistent with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition based on laboratory testing.
Therefore, the Delta TT Acetabular System and Delta Dual Mobility System are surgical implants, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- · Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
- · Rheumatoid arthritis;
- · Post-traumatic arthritis.
- · Correction of functional deformity;
- · Fractures, dislocation of the hip and unsuccessful cup arthroplasty.
- · Revisions in cases of good remaining bone stock.
Delta TT cup is intended for cementless use.
The Delta Dual Mobility System is intended to be used with Delta TT Acetabular System.
Product codes (comma separated list FDA assigned to the subject device)
LZO, LPH, MBL
Device Description
The subject Delta Dual Mobility System represents a dual mobility option for Delta TT acetabular system.
The Delta Dual Mobility System is intended for cementless use in total hip arthroplasty. The system is composed of an acetabular cup shell (previously cleared in K112898, K141395), a fixed liner, a mobile liner and a femoral head (previously cleared in K112158, K141327, K143509). Only femoral heads with offset S, M and L are intended to be used with Delta Dual Mobility System. The femoral head can be coupled with the previously cleared femoral stems. Bone screws that can optionally be used for additional fixation were cleared in K112898, K141395 and K172456.
The previously cleared acetabular cup shells are manufactured in titanium alloy: 14 cup shell sizes are intended to be used with dual mobility option. The CoCrMo fixed liners and the UHMWPE mobile liners are both available in 2 sizes. The previously cleared femoral heads are available in CoCrMo and Biolox Delta versions. Bone screws are provided for optional use to provide further primary fixation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
Non-Clinical Testing:
Results from mechanical tests and engineering analysis demonstrate the proposed Delta Dual Mobility System is substantially equivalent to the predicate devices.
Mechanical tests were performed on worst case components or constructs. The following tests were performed:
- Pull-out and Lever-out of mobile liner;
- Fixed liner push-out, lever-out and torque-out;
- Fatigue-fretting off-axis;
- Fatigue rim impingement;
- . Wear.
A simulation of Range of Motion has been performed to ensure the device design does not overly limit range of motion.
The tests results demonstrated the device's ability to perform under expected clinical conditions. LAL testing has been performed to establish that the subject device meets the specified 20EU/device limit.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Delta Dual Mobility System to the 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.
K150522, K161190, K103233, K112556, K112898, K141395, K070278, K110135, K122244, K023357, K032396, K042051, K070369
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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
Limacorporate S.p.A. % Stephen Peoples President Peoples & Associates Consulting LLC 5010 Lodge Pole Lane Fort Wayne, Indiana 46814
Re: K181491
Trade/Device Name: Delta Dual Mobility System Regulation Number: 21 CFR 888.3353 Regulation Name: Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis Regulatory Class: Class II Product Code: LZO, LPH, MBL Dated: April 16, 2019 Received: April 19, 2019
Dear Stephen Peoples:
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
May 9, 2019
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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.
For CAPT Raquel Peat Director OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality 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) K181491
Device Name Delta Dual Mobility System
Indications for Use (Describe)
The Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- · Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
- · Rheumatoid arthritis;
- · Post-traumatic arthritis.
- · Correction of functional deformity;
- · Fractures, dislocation of the hip and unsuccessful cup arthroplasty.
- · Revisions in cases of good remaining bone stock.
Delta TT cup is intended for cementless use.
The Delta Dual Mobility System is intended to be used with Delta TT Acetabular System.
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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3
Summary of Safety and Effectiveness
Date: May 5th, 2019
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Dr. Stephen J. Peoples Principal Consultant SPeoplesVMD@gmail.com PEOPLES & ASSOCIATES CONSULTING, LLC 411 Auditorium Blvd. Winona Lake, IN 46590 Phone: 260-645-0327 FAX: +39 0432945512
| Product | Common
Name | Product Code | Regulation and Classification Name |
|----------------------------------|-------------------------|--------------|--------------------------------------------------------------------------------------------------------------------------------|
| Delta Dual
Mobility
System | Total Hip
Prosthesis | LZO | Hip joint, Semi-Constrained,
Metal/Ceramic/Polymer, Cemented Or
Non-Porous, Uncemented prosthesis, per
21CFR 888.3353 |
| | | LPH, MBL | Hip joint metal/polymer/metal semi-
constrained porous-coated uncemented
prosthesis, per 21 CFR 888.3358 |
Description:
The subject Delta Dual Mobility System represents a dual mobility option for Delta TT acetabular system.
The Delta Dual Mobility System is intended for cementless use in total hip arthroplasty. The system is composed of an acetabular cup shell (previously cleared in K112898, K141395), a fixed liner, a mobile liner and a femoral head (previously cleared in K112158, K141327, K143509). Only femoral heads with offset S, M and L are intended to be used with Delta Dual Mobility System. The femoral head can be coupled with the previously cleared femoral stems. Bone screws that can optionally be used for additional fixation were cleared in K112898, K141395 and K172456.
The previously cleared acetabular cup shells are manufactured in titanium alloy: 14 cup shell sizes are intended to be used with dual mobility option. The CoCrMo fixed liners and the UHMWPE mobile liners are both available in 2 sizes. The previously cleared femoral heads are available in CoCrMo and Biolox Delta versions. Bone screws are provided for optional use to provide further primary fixation.
Traditional 510(k) - Delta Dual Mobility System May 5th, 2019 - UPDATE
4
Intended Use:
The Delta TT Acetabular System is indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:
- . Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia:
- . Rheumatoid arthritis:
- Post-traumatic arthritis,
- Correction of functional deformity:
- Fractures, dislocation of the hip and unsuccessful cup arthroplasty. .
- Revisions in cases of good remaining bone stock.
Delta TT cup is intended for cementless use.
The Delta Dual Mobility System is intended to be used with Delta TT Acetabular System.
Predicate Devices:
- G7 Dual Mobility System (Zimmer Biomet, K150522, K161190); ●
- MDM X3 (Stryker/Howmedica, K103233, K112556); ●
- Delta-TT acetabular System (Limacorporate, K112898, K141395);
- . Polarcup Dual Mobility System (Smith&Nephew, K070278, K110135, K122244).
- . Regenerex RingLoc + Modular acetabular shell and ArComXL polyethylene liners (Biomet, K023357, K032396, K042051, K070369).
Comparable Features to Predicate Device(s):
The intended use and indications of the Delta Dual Mobility System are the same as those of the previously cleared Delta TT Acetabular System. The Delta Dual Mobility System components are similar to the predicate devices components in terms of technical characteristics, materials, sizes, device usage, sterility and expiration / shelf life.
Non-Clinical Testing:
Results from mechanical tests and engineering analysis demonstrate the proposed Delta Dual Mobility System is substantially equivalent to the predicate devices.
Mechanical tests were performed on worst case components or constructs. The following tests were performed:
- Pull-out and Lever-out of mobile liner;
- Fixed liner push-out, lever-out and torque-out;
- Fatigue-fretting off-axis;
- Fatigue rim impingement;
- . Wear.
A simulation of Range of Motion has been performed to ensure the device design does not overly limit range of motion.
Traditional 510(k) - Delta Dual Mobility System May 5th, 2019 - UPDATE
5
The tests results demonstrated the device's ability to perform under expected clinical conditions. LAL testing has been performed to establish that the subject device meets the specified 20EU/device limit.
Clinical Testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Delta Dual Mobility System to the predicate devices.
Traditional 510(k) – Delta Dual Mobility System May 5th, 2019 - UPDATE