(118 days)
Not Found
No
The document describes a mechanical implant for hip replacement and does not mention any software, algorithms, or data processing capabilities that would indicate the use of AI/ML.
Yes
The device is an acetabular system used in total hip arthroplasty to reduce pain and improve hip function, clearly indicating a therapeutic purpose.
No.
This device is an orthopedic implant (acetabular system) intended for use in total hip arthroplasty, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of titanium alloy, UHMWPE, ceramic, and cobalt chrome molybdenum alloy, indicating it is a hardware device.
Based on the provided information, 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, which is a medical procedure performed in vivo (within the body). IVDs are used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device description details the components of a hip implant (cup, liner, femoral head, screws) made of materials like titanium alloy, UHMWPE, and ceramic/cobalt chrome. These are materials used for surgical implants, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, calibrators, controls, or any other components typically associated with in vitro diagnostic devices.
Therefore, the Delta Acetabular System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Delta 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;
- · Revision of previously failed total hip arthroplasty (Delta Multihole TT Pro only).
The Delta Acetabular System is intended for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
LPH, MBL
Device Description
The Delta Multihole TT Pro Acetabular System consists of a Delta Multihole TT Pro cup, an acetabular liner and a modular femoral head. Bone screws can also be used to provide additional stability of the cup.
The Delta Multihole TT Pro cup is manufactured from titanium alloy; the Delta Multihole TT Pro liners are manufactured from cross-linked UHMWPE with Vitamin E and the femoral heads made of Biolox Delta ceramic or Cobalt Chrome Molybdenum alloy.
The design of shell is similar to the previously cleared sizes of Delta Multihole TT Pro Acetabular System (K191622) and the G7 Acetabular System (Biomet, Inc., K140669) devices. The acetabular liners, the Biolox Delta heads, the CoCrMo heads and the bone screws are the same as those cleared in K182099. The Multihole TT Pro cup has a hemispherical design and provides holes in cranial and caudal aspects of the cup to provide additional cup stability by means of fixation screws. The Multihole TT Pro cup is coupled with a Delta TT Pro acetabular liner that is available in neutral, protruded and high wall versions.
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:
Mechanical testing had demonstrated the device's ability to perform in a substantially equivalent manner to the predicate devices in terms of:
- Push-out, lever-out and torque-out test according to ASTM F1820-13
- Deformation test according to ISO 7206-12:2016
- Unsupported anatomical fatigue deformation
Clinical testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Delta Multihole TT Pro Acetabular 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.
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
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Limacorporate S.P.A. % Lacey Harbour Regulatory Manager Lima USA Inc. 2001 NE Green Arlington, Texas 76006
Re: K200656
Trade/Device Name: Delta Multihole TT Pro Acetabular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip Joint Metal/Polymer/Metal Semi-Constrained Porous-Coated Uncemented Prosthesis Regulatory Class: Class II Product Code: LPH, MBL Dated: February 21, 2020 Received: March 12, 2020
Dear Lacey Harbour:
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
July 8, 2020
1
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) 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 (QS) 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 medical devices and radiation-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 Vesa Vuniqi, MS Assistant Director DHT6A: Division of Joint Arthroplasty 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) K200656
Device Name
Delta Multihole TT Pro Acetabular System
The Delta 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;
- · Revision of previously failed total hip arthroplasty (Delta Multihole TT Pro only).
The Delta Acetabular System is intended for cementless use.
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)
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3
510(k) Summary
Date: April 28, 2020
Manufacturer: Limacorporate S.p.A. Via Nazionale, 52 33038 - Villanova di San Daniele Udine - Italy
U.S. Contact Person: Lacey Harbour, MB(ASCP)CM US Regulatory Manager Lacey.harbour@limacorporate.com Limacorporate S.p.A. 2001 NE Green Oaks Blvd. Ste.100 Arlington, Texas 76006 USA www.limacorporate.com Office Phone: 817.385.0777 ext.200 Cell Phone: 432.638.6615 FAX: 817.385.0377
| Product | Product Code | Regulation and Classification Name |
|---|---|---|
| Delta Multihole TT Pro | ||
| Pro Acetabular System | LPH, MBL | Hip joint metal/polymer/metal semi-constrained |
| porous-coated uncemented prosthesis per 21 | ||
| CFR 888.3358 |
Common name:
Acetabular Cup System
Description:
The Delta Multihole TT Pro Acetabular System consists of a Delta Multihole TT Pro cup, an acetabular liner and a modular femoral head. Bone screws can also be used to provide additional stability of the cup.
The Delta Multihole TT Pro cup is manufactured from titanium alloy; the Delta Multihole TT Pro liners are manufactured from cross-linked UHMWPE with Vitamin E and the femoral heads made of Biolox Delta ceramic or Cobalt Chrome Molybdenum alloy.
The design of shell is similar to the previously cleared sizes of Delta Multihole TT Pro Acetabular System (K191622) and the G7 Acetabular System (Biomet, Inc., K140669) devices. The acetabular liners, the Biolox Delta heads, the CoCrMo heads and the bone screws are the same as those cleared in K182099. The Multihole TT Pro cup has a hemispherical design and provides holes in cranial and caudal aspects of the cup to provide additional cup stability by means of fixation screws. The Multihole TT Pro cup is coupled with a Delta TT Pro acetabular liner that is available in neutral, protruded and high wall versions.
4
Intended Use/Indications:
The Delta 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; ●
- o Revision of previously failed total hip arthroplasty (Delta Multihole TT Pro only).
The Delta Acetabular System is intended for cementless use.
Predicate Devices:
The LimaCorporate Delta Multihole TT Pro Acetabular System is similar to the following cleared devices in regard to design features, indications, and materials:
- Delta Multihole TT Pro Acetabular System (LimaCorporate, K191622), primary ● predicate
- Delta TT Pro (LimaCorporate, K182099) ●
- G7 Acetabular System (Biomet, Inc., K140669) ●
Summary of technology comparison:
The intended use, design, and materials of the Delta Multihole TT Pro Acetabular System are substantially equivalent to the intended use, design, and materials of the predicate devices. Design Control Activities have been completed and the results indicated that the subject device is safe and effective.
Non-clinical testing :
Mechanical testing had demonstrated the device's ability to perform in a substantially equivalent manner to the predicate devices in terms of:
- Push-out, lever-out and torque-out test according to ASTM F1820-13 ●
- Deformation test according to ISO 7206-12:2016 ●
- Unsupported anatomical fatigue deformation ●
Clinical testing:
Clinical testing was not necessary to demonstrate substantial equivalence of the Delta Multihole TT Pro Acetabular System to the predicate devices.