(105 days)
No
The 510(k) summary describes a mechanical implant (acetabular shell) and its materials and testing, with no mention of software, algorithms, or AI/ML capabilities.
Yes
The device, REDAPT Modular Acetabular Shells, is part of a hip replacement system intended for individuals undergoing primary and revision surgery to rehabilitate damaged hips. This directly aligns with the definition of a therapeutic device, as it is used to treat or alleviate a medical condition.
No
This device, the REDAPT Modular Acetabular Shells, is a hip component used in primary and revision surgery to replace damaged hips. It is an implantable device, not a diagnostic one. Its purpose is to treat conditions, not to diagnose them.
No
The device description clearly states the device is a physical implant made from titanium alloy powder through an additive manufacturing process. It is a hip component intended for surgical implantation.
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 hip replacement and revision surgery. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a physical implant made of titanium alloy, designed to be surgically implanted into the hip.
- Performance Studies: The performance studies focus on mechanical testing, fatigue, corrosion, and biocompatibility – all relevant to a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue), detecting specific analytes, or providing diagnostic information.
Therefore, the REDAPT Modular Acetabular Shells are a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The REDAPT Modular Acetabular Shells 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; fracturedislocation of the hip; and correction of deformity.
The REDAPT Modular Acetabular Shell is for single use only and is intended for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
LPH, MBL
Device Description
The subject of this Traditional 510(k) is the REDAPT Modular Acetabular Shells. The REDAPT Modular Acetabular Shells are a line extension to the REDAPT Porous Acetabular Shells to allow the un-cemented use of R3 Poly liners. The REDAPT Porous Acetabular Shells were previously cleared for market via premarket notification K150790.
The REDAPT Modular Acetabular Shells are available in same size range as REDAPT Porous Acetabular Shells from 48 mm to 80 mm. The REDAPT Modular Acetabular Shells are made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process and has identical porous structure as the predicate REDAPT Porous Acetabular Shell. The inner surface of the subject REDAPT Modular Acetabular shell is modified by a machining process to have an identical inner geometry and locking mechanism as the R3 Multi-hole shells to allow the uncemented use of R3 poly liners that are cleared to use with R3 Multi-hole Shell. The R3 Multi-hole Shells are most recently cleared under premarket notification K092386.The R3 XLPE liners were cleared under 510(k) K070756 and K113848 and the R3 Constrained Liners were cleared under K111635, K122139 and K162641.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip
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)
Non-clinical bench (mechanical) testing were conducted on the REDAPT Modular Acetabular Shell.
Tests performed:
- Acetabular Shell and Poly Liner Dissociation Testing-Push-in, Push-put, Lever-out and Torque to Failure testing
- Finite Element Analysis
- Fatigue test
- Corrosion
- Biocompatibility
- Bacterial endotoxin testing
A review of the mechanical data and the technical memo, indicates that the REDAPT Modular Acetabular Shells are substantially equivalent to 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.
K070756, K113848, K111635, K122139, K162641
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
| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Devices Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date of Submission: | August 2, 2018 |
| Contact Person: | Meenakshi Gupta, Sr. Regulatory Affairs Specialist
T (901) 399-6139
F (901) 721-2748 |
| Name of Device: | REDAPT Modular Acetabular Shell |
| Common Name: | Total Hip Joint, Acetabular Component |
| Device Classification Name
and Reference: | 21 CFR 888.3358 – Prosthesis, Hip, Semi-
Constrained, Metal/Polymer, Porous Uncemented |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | LPH, MBL |
| Predicate Device: | REDAPT Porous Acetabular Shell - K150790
R3 Shell Multi-Hole -K092386
REFLECTION Acetabular System-K920430
The predicate devices have not been subject to a
design related recall. |
1
Device Description:
The subject of this Traditional 510(k) is the REDAPT Modular Acetabular Shells. The REDAPT Modular Acetabular Shells are a line extension to the REDAPT Porous Acetabular Shells to allow the un-cemented use of R3 Poly liners. The REDAPT Porous Acetabular Shells were previously cleared for market via premarket notification K150790.
The REDAPT Modular Acetabular Shells are available in same size range as REDAPT Porous Acetabular Shells from 48 mm to 80 mm. The REDAPT Modular Acetabular Shells are made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process and has identical porous structure as the predicate REDAPT Porous Acetabular Shell. The inner surface of the subject REDAPT Modular Acetabular shell is modified by a machining process to have an identical inner geometry and locking mechanism as the R3 Multi-hole shells to allow the uncemented use of R3 poly liners that are cleared to use with R3 Multi-hole Shell. The R3 Multi-hole Shells are most recently cleared under premarket notification K092386.The R3 XLPE liners were cleared under 510(k) K070756 and K113848 and the R3 Constrained Liners were cleared under K111635, K122139 and K162641.
Intended Use
The REDAPT Modular Acetabular Shells 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
2
fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracturedislocation of the hip; and correction of deformity.
The REDAPT Modular Acetabular Shell is for single use only and is intended for cementless use.
The above indications are substantially equivalent to the indications cleared for the RADAPT Porous acetabular shell cleared under K150790 and R3 Multi-hole Shell Cleared under K092386.
Technological Characteristics
Device comparisons described in this premarket notification demonstrate that the subject device REDAPT Modular Acetabular Shell are substantially equivalent to the below listed legally marketed predicate devices with regard to intended use, indications for use, design, material and performance characteristics.
Substantial Equivalence Information
The overall design, materials, and indications for use for the REDAPT Modular Acetabular Shell are substantially equivalent to the following commercially available predicate devices.
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Smith & Nephew, Inc. | REDAPT Porous Acetabular Shell | K150790 (Primary) | 11/16/2015 |
| Smith & Nephew, Inc. | R3 Shell Multi-Hole | K092386 | 11/03/2009 |
| Smith & Nephew, Inc. | REFLECTION Acetabular System | K920430 | 07/21/1992 |
Table: Predicate Devices
3
Performance Testing
To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing were conducted on the REDAPT Modular Acetabular Shell. A review of the mechanical data and the technical memo, indicates that the REDAPT Modular Acetabular Shells are substantially equivalent to predicate devices listed in theTable above.
The following tests were used as a basis for the determination of substantial equivalence.
- . Acetabular Shell and Poly Liner Dissociation Testing-Push-in, Push-put, Lever-out and Torque to Failure testing
- o Finite Element Analysis
- Fatigue test
- . Corrosion
- . Biocompatibility
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.
All tests which are in relation to the porous structure characterization (physical, chemical or mechanical) have been cleared in the REDAPT Porous Acetabular shell 510(k) K150790.
Conclusion
As previously noted, this 510(k) Premarket Notification is being submitted to request clearance for the REDAPT Modular Shell. Based on the similarities to the predicate devices and a review of the mechanical testing performed, the subject device is substantially equivalent to the commercially available predicate devices listed above.
4
Indications for Use
510(k) Number (if known) K182109
Device Name REDAPT Modular Acetabular Shells
Indications for Use (Describe) The REDAPT Modular Acetabular Shells 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 (ND)D) 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 Modular Acetabular Shell is for single use only and is intended for cementless use.
| 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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5
| Submitted by: | Smith & Nephew, Inc.
Advanced Surgical Devices Division
7135 Goodlett Farms Parkway
Cordova, Tennessee 38016 |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Date of Submission: | August 2, 2018 |
| Contact Person: | Meenakshi Gupta, Sr. Regulatory Affairs Specialist
T (901) 399-6139
F (901) 721-2748 |
| Name of Device: | REDAPT Modular Acetabular Shell |
| Common Name: | Total Hip Joint, Acetabular Component |
| Device Classification Name
and Reference: | 21 CFR 888.3358 – Prosthesis, Hip, Semi-
Constrained, Metal/Polymer, Porous Uncemented |
| Device Class: | Class II |
| Panel Code: | Orthopaedics/87 |
| Product Code: | LPH, MBL |
| Predicate Device: | REDAPT Porous Acetabular Shell - K150790
R3 Shell Multi-Hole -K092386
REFLECTION Acetabular System-K920430 |
| | The predicate devices have not been subject to a
design related recall |
6
Device Description:
The subject of this Traditional 510(k) is the REDAPT Modular Acetabular Shells. The REDAPT Modular Acetabular Shells are a line extension to the REDAPT Porous Acetabular Shells to allow the un-cemented use of R3 Poly liners. The REDAPT Porous Acetabular Shells were previously cleared for market via premarket notification K150790.
The REDAPT Modular Acetabular Shells are available in same size range as REDAPT Porous Acetabular Shells from 48 mm to 80 mm. The REDAPT Modular Acetabular Shells are made from titanium alloy (Ti-6Al-4V) powder through an additive manufacturing process and has identical porous structure as the predicate REDAPT Porous Acetabular Shell. The inner surface of the subject REDAPT Modular Acetabular shell is modified by a machining process to have an identical inner geometry and locking mechanism as the R3 Multi-hole shells to allow the uncemented use of R3 poly liners that are cleared to use with R3 Multi-hole Shell. The R3 Multi-hole Shells are most recently cleared under premarket notification K092386.The R3 XLPE liners were cleared under 510(k) K070756 and K113848 and the R3 Constrained Liners were cleared under K111635, K122139 and K162641.
Intended Use
The REDAPT Modular Acetabular Shells 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
7
fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracturedislocation of the hip; and correction of deformity.
The REDAPT Modular Acetabular Shell is for single use only and is intended for cementless use.
The above indications are substantially equivalent to the indications cleared for the RADAPT Porous acetabular shell cleared under K150790 and R3 Multi-hole Shell Cleared under K092386.
Technological Characteristics
Device comparisons described in this premarket notification demonstrate that the subject device REDAPT Modular Acetabular Shell are substantially equivalent to the below listed legally marketed predicate devices with regard to intended use, indications for use, design, material and performance characteristics.
Substantial Equivalence Information
The overall design, materials, and indications for use for the REDAPT Modular Acetabular Shell are substantially equivalent to the following commercially available predicate devices.
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Smith & Nephew, Inc. | REDAPT Porous Acetabular Shell | K150790 (Primary) | 11/16/2015 |
| Smith & Nephew, Inc. | R3 Shell Multi-Hole | K092386 | 11/03/2009 |
| Smith & Nephew, Inc. | REFLECTION Acetabular System | K920430 | 07/21/1992 |
Table: Predicate Devices
8
Performance Testing
To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing were conducted on the REDAPT Modular Acetabular Shell. A review of the mechanical data and the technical memo, indicates that the REDAPT Modular Acetabular Shells are substantially equivalent to predicate devices listed in theTable above.
The following tests were used as a basis for the determination of substantial equivalence.
- Acetabular Shell and Poly Liner Dissociation Testing-Push-in, Push-put, Lever-out and Torque to Failure testing
- o Finite Element Analysis
- Fatigue test
- Corrosion
- . Biocompatibility
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.
All tests which are in relation to the porous structure characterization (physical, chemical or mechanical) have been cleared in the REDAPT Porous Acetabular shell 510(k) K150790.
Conclusion
As previously noted, this 510(k) Premarket Notification is being submitted to request clearance for the REDAPT Modular Acetabular Shell. Based on the similarities to the predicate devices and a review of the mechanical testing performed, the subject device is substantially equivalent to the commercially available predicate devices listed above.