(147 days)
Not Found
No
The document describes a mechanical hip implant system and its components, with no mention of software, algorithms, or any technology related to AI or ML.
Yes
The device is described as an implanted system (Total hip components) used for rehabilitating damaged hips, which is an explicit therapeutic purpose.
No
Explanation: The device is a total hip replacement system, indicated for primary and revision surgery to rehabilitate damaged hips. It is an implant used for treatment, not for diagnosing a condition.
No
The device description clearly states it is comprised of physical components (stem, modular neck, modular sleeve) made of titanium alloy with coatings, indicating it is a hardware medical device.
Based on the provided text, 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: The description clearly states that this device is a "Total hip component" comprised of a stem, modular neck, and modular sleeve. These are physical implants designed to be surgically placed within the body.
- Intended Use: The intended use describes the surgical implantation of these components to replace damaged hip joints. This is a surgical procedure, not a diagnostic test performed on a sample outside the body.
The device is an orthopedic implant, specifically a hip prosthesis.
N/A
Intended Use / Indications for Use
Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.
Product codes
MEH
Device Description
The MDF Revision Hip 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 MDF Revision Hip System construct. The Extra Small (XSM) Modular Sleeve line additions mate with similar size femoral stems in the MDF Revision Hip System and lock onto the proximal end of the stem. The XSM Modular Sleeves are manufactured from titanium alloy (Ti-6Al-4V). The XSM MDF Modular Sleeve line additions are grit-blasted and contain a threaded surface with a hydroxylapatite (HA) coating applied by a plasma spray technique.
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
- 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 disassociation, and post-fatigue disassociation have been evaluated. A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K100481 *"1/2
Smith & Nephew, Inc. Summary of Safety and Effectiveness MDF Revision Hip System Line Additions JUL 1 5 2010
Date of Summary: 07/14/2010
Contact Person and Address
Natalie P. Williams Regulatory Affairs Specialist Smith & Nephew, Inc. 1450 Brooks Road Memphis, TN 38116 (901)399-5161
Name of Device: Smith & Nephew MDF Modular Sleeve Common Name: Modular Sleeve Device Classification Name and Reference: 21 CFR 888.3353 Hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis Device Class: II Panel Code: Orthopaedics/87 MEH
Device Description
The MDF Revision Hip 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 MDF Revision Hip System construct. The Extra Small (XSM) Modular Sleeve line additions mate with similar size femoral stems in the MDF Revision Hip System and lock onto the proximal end of the stem. The XSM Modular Sleeves are manufactured from titanium alloy (Ti-6Al-4V). The XSM MDF Modular Sleeve line additions are grit-blasted and contain a threaded surface with a hydroxylapatite (HA) coating applied by a plasma spray technique.
Indications for Use
Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MDF Revision Hip 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
1
- 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 disassociation, and post-fatigue disassociation have been evaluated. A review of testing has demonstrated that there are no new issues related to the safety or effectiveness of the subject devices.
Substantial Equivalence Information
The overall design of the Smith & Nephew Extra Small MDF Modular Sleeve line additions is substantially equivalent to the modular sleeves that currently exist as part of the MDF Revision Hip System cleared via K081124. The XSM Modular Sleeves utilize an HA coating on a grit blasted surface to achieve comed hiss fixation and are substantially equivalent to the Synergy Press Fit Stem (K970337) also featuring USA coating on a roughened titanium substrate to achieve cementless fixation. Giving coosideration to the evice 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. Additional design detail is provided in Table 1 below.
| Device
Comparison | Modular Sleeves
Subject of K100481 | Predicate MDF Modular
Sleeves Subject of
K081124 | Predicate Synergy
Press Fit Stems
Subject of K970337 |
|----------------------|-----------------------------------------------------------|--------------------------------------------------------|------------------------------------------------------------|
| | HA on Grit Blast
Modular Sleeves | Stiktite plus HA Coated
Modular Sleeves | HA on Grit Blast
Press Fit Stems |
| Size Offering | Sizes 11 - 26/27; XSM | Sizes 11-25; S, M, L | Sizes 9-18 |
| Materials | | | |
| Substrate | Ti-6Al-4V per ASTM
F1472 | Ti-6Al-4V per ASTM
F1472 | Ti-6Al-4V per ASTM
F1472 |
| Roughened
Coating | N/A; substrate is grit-
blasted to roughen
surface. | CPTi per ASTM F67
(StikTite) | N/A; substrate is grit-
blasted to roughen
surface. |
| HA Coating | HA Coated per ASTM
F1185 | HA Coated per ASTM
F1185 | HA Coated per ASTM
F1185 |
Table 1: Comparison of Subject K100481 Modular Sleeves to Predicate Devices
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 5 2010
Smith & Nephew, Inc. % Ms. Natalie P. Williams 1450 Brooks Road Memphis, Tenessee 38116
Re: K100481
Trade/Device Name: Smith & Nephew MDF Modular Sleeve 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 Dated: July 8, 2010 Received: July 9, 2010
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
3
Page 2 - Ms. Natalie P. Williams
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 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.htmr.
Sincerely vours.
Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KI00481 510(k) Number (if known):
Device Name: Smith & Nephew MDF Modular Sleeve
Indications for Use:
Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteolomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew MDF Revision Hip System components are intended for single use only and are to be implanted without bone cement.
Prescription Use × (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)
Omtu for mxn
(Division Sign-Off)
(Division Sign rthopedic, Division of Surgical, O and Restorative Devices
Page 1 of
510(k) Number K100481