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 Modular Acetabular Shell is for single use only and is intended for cementless use.

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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the REDAPT Modular Acetabular Shell.

It's important to note that this document is a Traditional 510(k) submission, which aims to demonstrate substantial equivalence to predicate devices, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" and "study" are interpreted within the context of showing equivalence to existing, cleared devices.

Summary of Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance
Mechanical Performance	Acetabular Shell and Poly Liner Dissociation Testing (Push-in, Push-out, Lever-out, Torque to Failure)	"REDAPT Modular Acetabular Shells are substantially equivalent to predicate devices..." (Implies that the device met or exceeded the performance of the predicate devices in these tests).
	Finite Element Analysis (FEA)	"REDAPT Modular Acetabular Shells are substantially equivalent to predicate devices..."
	Fatigue Test	"REDAPT Modular Acetabular Shells are substantially equivalent to predicate devices..."
Biocompatibility	Biocompatibility testing	"REDAPT Modular Acetabular Shells are substantially equivalent to predicate devices..."
Material Characteristics	Corrosion Testing	"REDAPT Modular Acetabular Shells are substantially equivalent to predicate devices..."
Sterility/Endotoxin	Bacterial Endotoxin testing (met acceptable endotoxin limits per FDA Guidance and ANSI/AAMI ST72)	Completed and met acceptable endotoxin limits.
Porous Structure	Physical, chemical, or mechanical characterization of porous structure	All tests related to porous structure characterization were previously cleared in the REDAPT Porous Acetabular Shell 510(k) K150790. (This implies direct equivalence or use of the same validated design).
Intended Use	Same as predicate devices	"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."
Design/Materials	Overall design, materials, and indications for use substantially equivalent to predicates	"The overall design, materials, and indications for use for the REDAPT Modular Acetabular Shell are substantially equivalent to the following commercially available predicate devices."

Study Details:

Sample size used for the test set and the data provenance:
- The document describes non-clinical bench (mechanical) testing and Finite Element Analysis (FEA). It does not specify sample sizes (e.g., number of shells tested) for each individual mechanical test. For FEA, it's a computational model, so a "sample size" in the traditional sense doesn't apply.
- Data provenance: Bench testing results are typically generated in a controlled laboratory environment. The document does not specify the country of origin of the data
- Retrospective or Prospective: These are laboratory-based mechanical tests, not clinical studies, so the terms "retrospective" or "prospective" are not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This submission relies on bench testing and comparison to predicate devices. It does not involve establishing a "ground truth" based on expert consensus for clinical interpretation or diagnosis. The "ground truth" for these tests are objective measurements against established engineering standards or comparisons to the performance of predicate devices.
- The "experts" involved would be engineers, material scientists, and quality assurance personnel responsible for conducting and interpreting the mechanical tests. Their specific numbers and qualifications are not detailed in this summary, but would be expected to be highly experienced in medical device testing.
Adjudication method for the test set:
- Not applicable. This is not a study requiring adjudication of expert opinions (like 2+1 or 3+1 consensus). The "adjudication" is based on whether the devices meet pre-defined engineering specifications or perform comparably to predicate devices in controlled bench tests.
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:
- No, an MRMC comparative effectiveness study was not done. This is a mechanical device, not an AI or imaging diagnostic tool. Therefore, human reader performance or AI assistance effects are irrelevant here.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable as this is a mechanical medical device, not an algorithm or AI system.
The type of ground truth used:
- The "ground truth" can be considered as:
  - Objective engineering standards and specifications: For mechanical tests like fatigue, dissociation, and biocompatibility, there are defined standards and acceptable limits.
  - Predicate device performance: The ultimate "ground truth" for this 510(k) is the demonstrated safe and effective performance of its predicate devices, K150790, K092386, and K920430, which the new device aims to be substantially equivalent to.
  - Laboratory measurements: Empirical data derived from the bench testing.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical bench testing for a physical medical device. Training sets are relevant for machine learning algorithms.
How the ground truth for the training set was established:
- Not applicable (see point 7).

In conclusion, the study supporting the REDAPT Modular Acetabular Shell primarily consists of non-clinical bench (mechanical) testing and analysis (including Finite Element Analysis) to demonstrate substantial equivalence to existing, legally marketed predicate devices. The "acceptance criteria" are met if the device performs comparably to or within the established safety and performance envelopes of the predicate devices and relevant engineering standards.

Summary

{0}------------------------------------------------

Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016
Date of Submission:	August 2, 2018
Contact Person:	Meenakshi Gupta, Sr. Regulatory Affairs SpecialistT (901) 399-6139F (901) 721-2748
Name of Device:	REDAPT Modular Acetabular Shell
Common Name:	Total Hip Joint, Acetabular Component
Device Classification Nameand 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 - K150790R3 Shell Multi-Hole -K092386REFLECTION Acetabular System-K920430The predicate devices have not been subject to adesign related recall.

{1}------------------------------------------------

Device Description:

Intended Use

The REDAPT Modular Acetabular Shells are indicated for:

{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

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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.

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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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Submitted by:	Smith & Nephew, Inc.Advanced Surgical Devices Division7135 Goodlett Farms ParkwayCordova, Tennessee 38016
Date of Submission:	August 2, 2018
Contact Person:	Meenakshi Gupta, Sr. Regulatory Affairs SpecialistT (901) 399-6139F (901) 721-2748
Name of Device:	REDAPT Modular Acetabular Shell
Common Name:	Total Hip Joint, Acetabular Component
Device Classification Nameand 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 - K150790R3 Shell Multi-Hole -K092386REFLECTION Acetabular System-K920430
	The predicate devices have not been subject to adesign related recall

{6}------------------------------------------------

Device Description:

Intended Use

The REDAPT Modular Acetabular Shells are indicated for:

{7}------------------------------------------------

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

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

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

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.

Regulation Number and Section

§ 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.