(90 days)
Not Found
No
The document describes hip replacement components and does not mention any AI or ML capabilities.
Yes
The device, consisting of hip components, is indicated for the treatment of various hip conditions resulting from trauma or degenerative joint diseases, directly aiming to rehabilitate or correct damaged hips.
No
The document describes hip components and related acetabular systems, which are used for surgical implantation to treat damaged hips. It does not mention any function for diagnosing conditions.
No
The device description explicitly states the subject of the notification is "CoCr and Oxinium Femoral Head line additions" and "R3 XLPE Acetabular Liner line additions," which are physical hip implant components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing hip components due to various conditions affecting the hip joint. This is a therapeutic device, not a diagnostic one.
- Device Description: The device description details physical components (femoral heads and acetabular liners) that are implanted into the body. IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a surgical implant or prosthetic device, not an IVD.
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 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 Reflection 3 Acetabular System is for single use only and is intended for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
MBL
Device Description
Subject of this Traditional Premarket Notification are CoCr and Oxinium Femoral Head line additions in sizes 40 and 44mm and R3 XLPE Acetabular Liner line additions with inner diameters of 40 and 44mm.
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)
Not Found
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.
K022902, K022958, K896580, K934353, K062408, K061253, K070756, K071160, K061434, K062148
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
§ 888.3358 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
510(k) Summary CoCr and Oxinium Femoral Heads and R3 XLPE Liners
Submitter's Name: Submitter's Address: Submitter's Telephone Number: Contact Person: Date Summary Prepared: Trade or Proprietary Device Name: Common or Usual Name: Classification Name:
Smith & Nephew, Inc., Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901-399-5340 Megan Bevill January 26, 2010 CoCr and Oxinium Femoral Heads and R3 XLPE Liners Femoral Heads and Acetabular Liners 21 CFR 888.3358 Hip joint metal/polymer/metal semiconstrained porous coated uncemented prosthesis Class II Orthopaedics/87/MBL
Device Class: Panel Code:
Device Description
Subject of this Traditional Premarket Notification are CoCr and Oxinium Femoral Head line additions in sizes 40 and 44mm and R3 XLPE Acetabular Liner line additions with inner diameters of 40 and 44mm.
Intended Use and Indications
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.
Substantial Equivalence
The subject CoCr and Oxinium Femoral Heads and R3 XLPE Liners are substantially equivalent to the predicate devices listed in the table below.
| Manufacturer | Description | Submission Number | Clearance Date |
|---|---|---|---|
| Smith & Nephew, | |||
| Inc. | 36mm CoCr Femoral Heads | K022902 | 10/2/02 |
| Smith & Nephew, | |||
| Inc. | 36mm Oxinium Femoral Heads | K022958 | 10/2/02 |
| Smith & Nephew, | |||
| Inc. | Unipolar Femoral Heads | K896580 | |
| K934353 | 2/15/90 | ||
| 4/25/94 | |||
| Smith & Nephew, | |||
| Inc. | Modular Femoral (Hemi) Heads | K062408 | 9/12/06 |
| Smith & Nephew, | |||
| Inc. | Reflection 3 Acetabular System | K061253 | |
| K070756 | 5/31/06 | ||
| 6/6/07 | |||
| Smith & Nephew, | |||
| Inc. | Reflection XLPE Acetabular | ||
| Liners | K071160 | 10/5/07 | |
| Stryker Orthopaedics | Trident Hip System | K061434 | 8/22/06 |
| Depuy Orthopaedics, | |||
| Inc. | Pinnacle Altrx Acetabular Cup | ||
| Liner | K062148 | 10/24/06 |
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an emblem of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Smith & Nephew Inc., Orthopaedic Division Ms. Megan Bevill Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
Received: October 28, 2009
JAN 2 3 2010
Re: K093363
Trade/Device Name: CoCr and Oxinium Femoral Heads and R3 XLPE Liners 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: MBL Dated: October 26, 2009
Dear Ms. Bevill:
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.
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
2
Page 2 - Ms. Megan Bevill
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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Millersen
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): 109 336 3
Device Name: CoCr and Oxinium Femoral Heads and R3 XLPE Liners
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 Reflection 3 Acetabular System is for single use only and is intended for cementless use.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use. (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Smita for mxm
(Division Sign-Off)
Division of Surgical. Othopedic, and Restorative Devices
510(k) Number K093363