(227 days)
No
The summary describes a mechanical hip implant component made of polyethylene with specific design features for cement fixation. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a hip component used in primary and revision surgery to rehabilitate hips damaged by various conditions, which aligns with the definition of a therapeutic device.
No
The device is a hip component (liner) designed for implantation during hip surgery to treat various hip conditions, not to diagnose them.
No
The device description clearly states it is a physical implantable component made from polyethylene, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a hip component (a physical implant) intended for surgical implantation to treat various hip conditions. It is a medical device used in vivo (within the body), not in vitro (outside the body).
- Lack of IVD Characteristics: The document does not mention any testing of biological samples, analysis of biomarkers, or any other activity associated with in vitro diagnostics.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an IVD.
N/A
Intended Use / Indications for Use
Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection: fracture-dislocation of the hip; and correction of deformity.
The REDAPT Cemented Liner is intended for single use only and is to be implanted with bone cement.
Product codes
JDI, KWZ, LZO
Device Description
The REDAPT Anteverted Cemented Liner is manufactured from highly cross-linked polyethylene (ASTM F648) via standard machining processes. The liners incorporate integral polyethylene spheres that create a 1.5 mm gap between the porous shell or natural acetabulum for a consistent bone cement mantle.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint
Indicated Patient Age Range
Not Found
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)
A review of the mechanical data indicates that the REDAPT Anteverted Liners are capable of withstanding expected in vivo loading without failure.
The following tests were used as a basis for the determination of substantial equivalence:
- Fatigue
- Push out, Lever Out, and Torque-to-Failure
- Range of Motion
- Impingement
Wear performance of the cross-linked polyethylene liners are substantially equivalent to the REDAPT 0-Degree Liners in K150790 and the REFLECTION Liners in K002747.
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 17, 2016
Smith & Nephew, Inc. Ms. Kim Phan Regulatory Affairs Specialist Advanced Surgical Devices Division 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K160923
Trade/Device Name: REDAPT Anteverted Cemented Liner Regulation Number: 21 CFR 888.3350 Regulation Name: Hip Joint Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JDI, KWZ, LZO Dated: October 27, 2016 Received: October 28, 2016
Dear Ms. Kim Phan:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson -S
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
510(k) Number (if known) K160923
Device Name REDAPT Anteverted Cemented Liner
Indications for Use (Describe)
· Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDID) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
· Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, atthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection: fracture-dislocation of the hip; and correction of deformity.
The REDAPT Cemented Liner is intended for single use only and is to be implanted with bone cement.
| 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
510(k) Summary Smith & Nephew REDAPT Anteverted Cemented Liner
| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Devices Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Date of Summary: | October 27th, 2016 |
| Contact Person | Kim Phan, Regulatory Affairs Specialist
T: (901) 800-3175
F: (901) 566-7034 |
| Name of Device: | REDAPT Anteverted Cemented Liner |
| Common Name: | Hip Prosthesis, Acetabular Component |
| Device Classification Name and Reference: | 21 CFR 888.3350 – Prosthesis, Hip, Sem
Constrained, Metal/Polymer, Cemented |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JDI, KWZ, LZO |
Device Description
The REDAPT Anteverted Cemented Liner is manufactured from highly cross-linked polyethylene (ASTM F648) via standard machining processes. The liners incorporate integral polyethylene spheres that create a 1.5 mm gap between the porous shell or natural acetabulum for a consistent bone cement mantle.
Intended Use
The REDAPT Anteverted Cemented Liner are indicated for:
- Hip components are indicated for individuals undergoing primary and revision surgery ● where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant.
- . Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
4
The REDAPT Cemented Liner is intended for single use only and is to be implanted with bone cement.
The above indications are substantially equivalent to the indications cleared for the REDAPT Cemented Liners cleared in K150790.
Technological Characteristics
A review of the mechanical data indicates that the REDAPT Anteverted Liners are capable of withstanding expected in vivo loading without failure.
Substantial Equivalence Information
The REDAPT Anteverted Cemented Liners are substantially equivalent to the following commercially available predicate devices by overall design, materials, or indications for use.
| Manufacturer | Description | Submission
Number | Clearance
Date | Predicate
Status |
|----------------|---------------------------------------------------------|----------------------|-------------------|---------------------------------|
| Smith & Nephew | REFLECTION Cross-Linked UHMWPE
Acetabular Components | K002747 | 12/15/2000 | Primary for
Cemented Liner |
| Smith & Nephew | REDAPT Porous Shell and
Cemented Liner | K150790 | 11/16/2015 | Primary for
Indications |
| Smith & Nephew | REFLECTION XLPE Acetabular Liner | K022902 | 10/2/2002 | Reference for
Cemented Liner |
| Smith & Nephew | R3 XLPE Acetabular Liner | K113848 | 4/24/2012 | Reference for
Cemented Liner |
The following tests were used as a basis for the determination of substantial equivalence:
- Fatigue ●
- Push out, Lever Out, and Torque-to-Failure ●
- Range of Motion ●
- Impingement
Wear performance of the cross-linked polyethylene liners are substantially equivalent to the REDAPT 0-Degree Liners in K150790 and the REFLECTION Liners in K002747.
Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in the FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxins Testing: Questions and Answers," and ANSI/AAMI ST72.
Conclusion
As previously noted, this 510(k) Premarket Notification is being submitted to request clearance for the REDAPT Anteverted Cemented Liner. Based on the similarities to the predicate component and a review of the mechanical testing performed, the devices are substantially equivalent to the commercially available predicate device listed above.