(133 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and materials of the hip implant components, with no mention of AI or ML.
Yes
The device, a hip component system, is intended to rehabilitate damaged hips, treat various degenerative joint diseases, fractures, and deformities, which are all therapeutic actions.
No
The device is a hip implant system used in revision surgery, not a diagnostic tool. Its purpose is to replace damaged hip components, not to diagnose a condition.
No
The device description clearly details physical components made of titanium alloy and cobalt chrome, intended for surgical implantation. There is no mention of software as the primary or sole component.
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 treating hip conditions. This involves direct intervention within the body.
- Device Description: The device is described as a physical implant (stem, neck, sleeve) made of titanium alloy and coated with materials for bone integration.
- Performance Studies: The performance studies focus on mechanical properties like fatigue strength, pull-off strength, and range of motion, which are relevant to the physical function of an implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a surgical implant, not an in vitro diagnostic device.
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 ioint disease (NIDJ) 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 theumatoid 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.
Smith & Nephew Redapt Revision Femoral System components are intended for single use only and are to be implanted without bone cement.
Product codes (comma separated list FDA assigned to the subject device)
MEH, LZO
Device Description
The Redapt Revision Femoral System is comprised of a stem, modular neck, and modular sleeve component. The components of the revision hip system modularly connect together to form the complete Redapt Revision Femoral System construct. Subject of this Abbreviated premarket notification are the Redapt Modular Sleeved Revision Hip Stems and size 26/27 Modular Sleeves. The Modular Sleeved Revision Hip Stem is a modification of the MDF Revision Hip Stem cleared via premarket notification K081124. The Modular Sleeved Revision Hip Stem is a straight, tapered, distally fixed, modular stem. The subiect device is manufactured from titanium alloy (Ti-6Al-4V), has a grit-blast finish, and is available in lengths of 240mm and 300mm in sizes 11-27. The Modular Sleeved Revision Hip Stems has a modular 12/14 female neck taper that mates with the cobalt chrome modular necks previously cleared in premarket notification K081124.
The size 26/27 Modular Sleeves are line additions to the Modular Sleeves cleared in K081124. The subject devices lock onto the proximal end of the stem to aid in proximal fixation. The size 26/27 Redapt Modular Sleeves are identical in design to the current modular sleeves cleared by K081124 and are also offered in the same small, medium, and large cone sizes. The subject devices are proportionally larger to accommodate the size 26/27 stems. The subject devices contain the Smith & Nephew Stiktite coating. A Hydroxyapatite (HA) coating will be applied to the Stiktite coated areas of the size 26/27 Redapt Modular Sleeves.
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)
Performance testing has been conducted for the subject devices in accordance with the following guidance documents:
- Non-Clinical Information for Femoral Stem Prostheses, dated September 2007
- Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked," Modular Implant . Components, dated May 1995
- Guidance Document for Testing Orthopaedic Implants with Modified Metallic Surfaces Apposing . Bone or Bone Cement, dated April 1994
- Calcium Phosphate (Ca-P) Coating Draft Guidance Document for Preparation of FDA Submissions . for Orthopaedic and Dental Endosseous Implants, dated February 1997
Environmental corrosion fatigue, pre-fatigue and post-fatigue pull-off, and fatigue strength testing were performed. The range of motion of the Modular Sleeved Revision Hip Stem was also evaluated. A review of the testing and analysis has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject 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
§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.
(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.
0
K121627 (pg 1/3).
Smith & Nephew, Inc. Summary of Safety and Effectiveness Redapt® Revision Femoral System
OCT 15 2012
Date of Summary: 6/1/12
Contact Person and Address Natalie P. Williams Sr. Regulatory Affairs Specialist Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016 (901) 399-5161
Name of Device: Smith & Nephew Redapt Revision Femoral System Common Name: Femoral Hip Prosthesis
Device Classification Name and Reference: 21 CFR 888.3353 Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Device Class: II
Device class, if
Panel Code: Orthopaedics/87 MEH, LZO
Device Description
The Redapt Revision Femoral System is comprised of a stem, modular neck, and modular sleeve component. The components of the revision hip system modularly connect together to form the complete Redapt Revision Femoral System construct. Subject of this Abbreviated premarket notification are the Redapt Modular Sleeved Revision Hip Stems and size 26/27 Modular Sleeves. The Modular Sleeved Revision Hip Stem is a modification of the MDF Revision Hip Stem cleared via premarket notification K081124. The Modular Sleeved Revision Hip Stem is a straight, tapered, distally fixed, modular stem. The subiect device is manufactured from titanium alloy (Ti-6Al-4V), has a grit-blast finish, and is available in lengths of 240mm and 300mm in sizes 11-27. The Modular Sleeved Revision Hip Stems has a modular 12/14 female neck taper that mates with the cobalt chrome modular necks previously cleared in premarket notification K081124.
The size 26/27 Modular Sleeves are line additions to the Modular Sleeves cleared in K081124. The subject devices lock onto the proximal end of the stem to aid in proximal fixation. The size 26/27 Redapt Modular Sleeves are identical in design to the current modular sleeves cleared by K081124 and are also offered in the same small, medium, and large cone sizes. The subject devices are proportionally larger to accommodate the size 26/27 stems. The subject devices contain the Smith & Nephew Stiktite coating. A Hydroxyapatite (HA) coating will be applied to the Stiktite coated areas of the size 26/27 Redapt Modular Sleeves.
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 ioint disease (NIDJ) 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 theumatoid 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
1
that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
Smith & Nephew Redapt Revision Femoral System components are intended for single use only and are to be implanted without bone cement.
Performance Data
Performance testing has been conducted for the subject devices in accordance with the following guidance documents:
- · Non-Clinical Information for Femoral Stem Prostheses, dated September 2007
- Draft Guidance Document for Testing Non-Articulating, "Mechanically Locked," Modular Implant . Components, dated May 1995
- Guidance Document for Testing Orthopaedic Implants with Modified Metallic Surfaces Apposing . Bone or Bone Cement, dated April 1994
- Calcium Phosphate (Ca-P) Coating Draft Guidance Document for Preparation of FDA Submissions . for Orthopaedic and Dental Endosseous Implants, dated February 1997
Environmental corrosion fatigue, pre-fatigue and post-fatigue pull-off, and fatigue strength testing were performed. The range of motion of the Modular Sleeved Revision Hip Stem was also evaluated. A review of the testing and analysis has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices.
Substantial Equivalence Information
The materials, intended use, indications for use, sterilization, and overall design of the Smith & Nephew Redapt Modular Sleeved Revision Hip Stems and size 26/27 Modular Sleeves are substantially equivalent to the MDF Revision Hip Stems and modular sleeves cleared by premarket notification K081124. Giving consideration to the device modifications described in the Device Description section, no changes have been made to the overall design philosophy, intended use, and material choices when compared to the predicate devices. A comparison of the subject devices to the predicate devices is provided in Table 1 below.
2
...
| Table 1: Comparison of the Redapt Hip Stems and Modular Sleeves to Predicate Devices | |
|---|---|
| -------------------------------------------------------------------------------------- | -- |
| Device Names | ||
|---|---|---|
| Design Features | Subject Smith & Nephew Redapt® | |
| Hip Stems and Modular Sleeves | Smith & Nephew MDF | |
| Revision Hip Stem System | ||
| (K081124) | ||
| Similar Indications for | ||
| Use/Intended Use | Yes | Yes |
| Similar Sterilization | Yes | Yes |
| Femoral Stems | ||
| Size Offering | 11-27 | 11-25 |
| Stem Lengths (mm) | 240mm; 300mm | 240mm; 300mm |
| Stem Material | Ti-6AL-4V per ASTM F1472 | Ti-6AL-4V per ASTM F1472 |
| Grit-blast Finish | Yes | Yes |
| Fluted Tapered Stem | Yes | Yes |
| Neck Taper | 12/14 | 12/14 |
| Cobalt Chrome | ||
| Modular Necks | Yes | Yes |
| Modular Sleeves | Subject Stiktite Plus HA Coated | |
| Modular Sleeves | Stiktite Plus HA Coated | |
| Modular Sleeves (K081124) | ||
| Size Offering | Size 26/27 | |
| Small, Medium, and Large | Sizes 11-25 | |
| Small, Medium, and Large | ||
| Materials | ||
| Substrate | Ti-6AL-4V per ASTM F1472 | Ti-6AL-4V per ASTM F1472 |
| Stiktite Coating | CP Ti per ASTM F 67 | CP Ti per ASTM F 67 |
| HA Coating | HA Coated per ASTM F1185 | HA Coated per ASTM F1185 |
Conclusion
This Abbreviated 510(k) Premarket Notification is being submitted to request clearance for the Redapt' Modular Sleeved Revision Hip Stems and size 26/27 Modular Sleeves. Based on the similarities to the predicate devices, the devices are substantially equivalent to the femoral stem and modular sleeve components currently marketed under K081124.
·
.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars above it, representing the department's commitment to health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle symbol. The logo is simple and recognizable, conveying the department's mission and purpose.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith and Nephew, Incorporated % Ms. Natalie P. Williams Senior Regulatory Affairs Specialist 7135 Goodlett Farms Parkway Cordova, Tennessee 38016
OCT 1.5 2012
Re: K121627
Trade/Device Name: Smith and Nephew Redapt Revision Femoral System Regulation Number: 21 CFR 888.3353
Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Regulatory Class: Class II Product Code: MEH, LZO Dated: September 28, 2012 Received: October 1, 2012
Dear Ms. Williams:
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
4
Page 2 - Ms. Natalie P. Williams
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
tory yours,
for
N. Mcllveen
Mark N. Melkerson " Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known): K121627 cpg 1/1)
Device Name: Smith & Nephew Redapt® Revision Femoral System
Indications for Use:
r. . .
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.
Smith & Nephew Redapt Revision Femoral System components are intended for single use only and are to be implanted without bone cement.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
K. Asad
ion Sign-Off)
of Surgi. & Orthopedic,
:oralive Devices
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