(236 days)
The REDAPT Porous Acetabular Shell and 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.
The REDAPT Porous Acetabular Shell is intended for single use only and is to be implanted without bone cement. The REDAPT Cemented Liner is intended for single use only and is to be implanted with bone cement.
The REDAPT Porous Acetabular Shell designed for cementless use is made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process. The device design allows for the cementing of cross-linked polyethylene liners into the shell and incorporates screw holes for fixation. The REDAPT 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.
This document is a 510(k) summary for the REDAPT Porous Acetabular Shell and Cemented Liner, a medical device. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on comparing the new device against existing ones rather than detailing a traditional study with acceptance criteria and a detailed analysis of performance metrics in clinical trials.
Therefore, the requested information categories (#1-7 for a study and its acceptance criteria, and specific details for #8-9 for training sets) are generally not applicable in the context of this medical device submission. The FDA 510(k) process for devices like this typically relies on bench testing, material characterization, and comparisons to predicate devices to establish substantial equivalence, rather than extensive human clinical trials or AI performance evaluations.
However, I can extract the information provided that is relevant to the nature of this submission:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for a study with reported device performance in the way one might expect for a clinical trial or AI performance evaluation. Instead, it lists various tests performed to establish substantial equivalence. The "performance" is implied by the successful completion of these tests and the determination of substantial equivalence to predicate devices, meaning the device performed comparably or met established standards for the indicated tests.
The listed tests are:
| Test Type | Performance Claim / Outcome |
|---|---|
| Porous structure characterization | Details discussed in Porous Structure Master File MAF – 2596. Includes: Composition, Trace element, Microstructure, Strut shape and size, Surface pore diameter, Mean void intercept length, Porosity, Shear mechanical properties, Tensile mechanical properties, Bending mechanical properties, Compressive mechanical properties, Abrasion resistance. Implied Outcome: Met established specifications for each. |
| Construct fatigue testing | A review of the mechanical data indicates that the REDAPT Porous Acetabular Shell and Cemented Liner are capable of withstanding expected in vivo loading without failure. Implied Outcome: Met fatigue endurance requirements. |
| Acetabular screw testing | Implied Outcome: Met mechanical requirements for screw fixation. |
| Cemented liner testing | Implied Outcome: Met mechanical requirements specific to cemented liners. |
| Biocompatibility | Implied Outcome: Biocompatible according to relevant standards. |
| Range of Motion | Implied Outcome: Achieved acceptable range of motion without impingement. |
| Impaction | Implied Outcome: Demonstrated acceptable impaction characteristics. |
| Wear performance | Addressed based on a comparison of the minimum thickness in the rim and load bearing regions of the liners with the predicate devices. Implied Outcome: Wear performance is comparable to predicate devices. |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for each test. For mechanical and material tests of medical devices, sample sizes are typically determined by relevant ISO or ASTM standards (e.g., 5-10 samples per test group). The document does not provide these details.
- Data Provenance: Not specified. Standard practice for such tests would be laboratory testing conducted by the manufacturer or a contracted testing facility in a controlled environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. This is a submission for a physical medical device (hip implant components), not for an interpretative AI/imaging device. "Ground truth" in this context would refer to the validated material properties, mechanical performance under specified loads, and biocompatibility, which are established through standardized laboratory testing protocols, not expert consensus on interpretations.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as this is not a study requiring adjudication of expert opinions.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a physical hip implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical hip implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's evaluation relies on:
- Physical and Chemical Material Standards: Adherence to established ASTM (e.g., ASTM F648 for cross-linked polyethylene) and ISO standards for materials like titanium alloy and polyethylene.
- Mechanical Test Standards: Compliance with relevant mechanical testing standards (e.g., for fatigue, screw fixation, wear simulation) that simulate in vivo conditions.
- Biocompatibility Standards: Compliance with ISO 10993 series or similar standards for biological evaluation of medical devices.
- Comparison to Predicate Devices: Performance characteristics (e.g., wear, mechanical strength) found to be substantially equivalent to those of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. There is no AI component or "training set" in the context of this device's submission.
9. How the ground truth for the training set was established
Not applicable.
{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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 16, 2015
Smith & Nephew Incorporated Mr. Jeff Sprague Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
Re: K150790
Trade/Device Name: REDAPT Porous Acetabular Shell and Cemented Liner 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, JDI, KWZ, LZO Dated: October 2, 2015 Received: October 5, 2015
Dear Mr. Sprague:
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
{1}------------------------------------------------
Page 2 - Mr. Jeff Sprague
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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" (21CFR 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
{2}------------------------------------------------
INDICATIONS FOR USE Smith & Nephew REDAPT Porous Acetabular Shell and Cemented Liner
510(k) Number (if known): K150790
Device Name: REDAPT Porous Acetabular Shell and Cemented Liner
Indications for Use:
The REDAPT Porous Acetabular Shell and 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.
The REDAPT Porous Acetabular Shell is intended for single use only and is to be implanted without bone cement. The REDAPT Cemented Liner is intended for single use only and is to be implanted with bone cement.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{3}------------------------------------------------
510(k) Summary Smith & Nephew REDAPT Porous Acetabular Shell and Cemented Liner
| Submitted by: | Smith & Nephew, Inc.Advanced Surgical Devices Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016 |
|---|---|
| Date of Summary: | November 10th, 2015 |
| Contact Person | Jeff Sprague, Regulatory AffairsT (901) 399-5215 F (901) 721-2736 |
| Name of Device: | REDAPT Porous Acetabular Shell andCemented Liner |
| Common Name: | Total Hip Joint, Acetabular Component |
| Device Classification Name and Reference: | 21 CFR 888.3358 – Hip jointmetal/polymer/metal semi-constrainedporous-coated uncemented prosthesis21 CFR 888.3350 – Hip joint metal/polymersemi-constrained cemented prosthesis |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | JDI, KWZ, LZO, LPH |
Device Description
The REDAPT Porous Acetabular Shell designed for cementless use is made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process. The device design allows for the cementing of cross-linked polyethylene liners into the shell and incorporates screw holes for fixation. The REDAPT 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 Porous Acetabular Shell and 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.
{4}------------------------------------------------
- . 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.
The REDAPT Porous Acetabular Shell is intended for single use only and is to be implanted without bone cement. The REDAPT Cement 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 R3 acetabular shell cleared in K070756.
Technological Characteristics
A review of the mechanical data indicates that the REDAPT Porous Acetabular Shell and Cemented Liner are capable of withstanding expected in vivo loading without failure.
Substantial Equivalence Information
The overall design, materials, and indications for use for the REDAPT Porous Acetabular Shell and Cemented Liner are substantially equivalent to the following commercially available predicate devices.
| Manufacturer | Description | SubmissionNumber | ClearanceDate | PredicateStatus |
|---|---|---|---|---|
| Zimmer TrabecularMetal Technology | Trabecular Metal AcetabularRevision Shells | K050937 | 5/11/2005 | Primary forPorous Shell |
| Smith & Nephew | REFLECTION 3 Acetabular System | K060630 | 6/6/2007 | Reference forPorous Shell |
| Smith & Nephew | REFLECTION AcetabularReinforcement Rings | K962541 | 9/17/1996 | Reference forPorous Shell |
| Smith & Nephew | REFLECTION Cross-Linked UHMWPEAcetabular Components | K002747 | 12/15/2000 | Primary forCemented Liner |
| Smith & Nephew | REFLECTION XLPE Acetabular Liner | K022902 | 10/2/2002 | Reference forCemented Liner |
| Smith & Nephew | R3 XLPE Acetabular Liner | K113848 | 4/24/2012 | Reference forCemented Liner |
| Smith & Nephew | R3 Acetabular Shell | K070756 | 6/6/2007 | Primary forIndications |
{5}------------------------------------------------
The following tests were used as a basis for the determination of substantial equivalence:
- Porous structure characterization ●
- o Composition
- Trace element O
- Microstructure O
- Strut shape and size O
- Surface pore diameter O
- Mean void intercept length o
- Porosity O
- Shear mechanical properties o
- Tensile mechanical properties o
- Bending mechanical properties O
- Compressive mechanical properties O
- Abrasion resistance o
- Construct fatigue testing ●
- Acetabular screw testing ●
- Cemented liner testing ●
- Biocompatibility ●
- Range of Motion ●
- . Impaction
Wear performance of the cross-linked polyethylene liners in the subject system was addressed based on a comparison of the minimum thickness in the rim and load bearing regions of the liners with the predicate devices.
All tests which are in relation to the porous structure characterization (physical, chemical or mechanical) are discussed in detail in the Porous Structure Master File MAF – 2596 and are not included in this 510(k).
Conclusion
As previously noted, this 510(k) Premarket Notification is being submitted to request clearance for the REDAPT Porous Acetabular Shell and 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.
§ 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.