(78 days)
No
The document describes a ceramic femoral head component for hip replacement, focusing on material, size, and mechanical performance testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device is a component of a hip implant system used to rehabilitate damaged hips, which is a therapeutic purpose.
No
The provided text describes hip components (femoral heads) intended for surgical implantation to rehabilitate damaged hips. These devices are used for treatment and replacement, not for diagnosing conditions.
No
The device description clearly states that the subject devices are "ceramic femoral head components," which are physical hardware implants. The entire summary focuses on the material, size, and mechanical performance testing of these physical components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text clearly states the device is a hip component intended for surgical implantation to treat various hip conditions. This is a therapeutic device, not a diagnostic one.
- Device Description: The description details a ceramic femoral head component used in hip replacement surgery. This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Language: The text does not mention any terms or concepts related to in vitro diagnostics, such as analyzing biological samples, detecting diseases or conditions outside the body, or providing information for diagnosis.
The device described is a medical device, specifically a prosthetic implant, used in surgical procedures.
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 rehabilitatiing 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.
Product codes
LZO
Device Description
Subject of this Traditional Premarket Notification are Biolox Delta Ceramic Femoral Head line additions. The subject devices are ceramic femoral head components which are intended to be used in conjunction with existing Smith & Nephew 12/14 taper hip stems, and they are intended to articulate against appropriately sized, existing XLPE acetabular liners. The Biolox Delta Ceramic Femoral Heads are manufactured from Biolox delta ceramic material and will be offered in sizes 40 and 44mm with offsets of 0, +4, and +8mm.
Biolox Detta Ceramic Femoral Heads in smaller sizes (28, 32, and 36mm) have previously been cleared for market via premarket notification K083762. The only difference between the subject Biolox Delta Ceramic Femoral Heads and those cleared via K083762 is the size offering: the subject devices are offered with a larger diameter than the predicate devices. All other design features, including material choice, taper design, and articular surface finish, are identical. Additionally, Biolox Delta Ceramic Femoral Heads in the same size range have previously been cleared for market via K082844.
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
Performance testing has been conducted for the subject devices in accordance with the guidance titled "Draft Guidance Document for Testing Non-articulating, 'Mechanically Locked,' Modular Implant Components," dated May 1, 1995, "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995, and "Draft Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems", dated January 10, 1995. Range of motion, femoral head burst, femoral head fatigue, wear performance, assembly/disassembly strength, and head/stem construct fatigue have been evaluated. A review of the testing 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 device.
Key Metrics
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
Summary of Safety and Effectiveness Biolox Delta Ceramic Femoral Heads Smith & Nephew, Inc.
Contact Person and Address Megan Bevill Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116 T (901) 399-5340
Date of Summary: April 27, 2010
MAY - 5 2010
Name of Device: Biolox Delta Ceramic Femoral Heads
Common Name: Femoral Heads
Device Classification Name and Reference: 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Device Class: Class II
Panel Code: Orthopaedics/87 LZO
Device Description
Subject of this Traditional Premarket Notification are Biolox Delta Ceramic Femoral Head line additions. The subject devices are ceramic femoral head components which are intended to be used in conjunction with existing Smith & Nephew 12/14 taper hip stems, and they are intended to articulate against appropriately sized, existing XLPE acetabular liners. The Biolox Delta Ceramic Femoral Heads are manufactured from Biolox delta ceramic material and will be offered in sizes 40 and44mm with offsets of 0, +4, and +8mm.
Biolox Detta Ceramic Femoral Heads in smaller sizes (28, 32, and 36mm) have previously been cleared for market via premarket notification K083762. The only difference between the subject Biolox Delta Ceramic Femoral Heads and those cleared via K083762 is the size offering: the subject devices are offered with a larger diameter than the predicate devices. All other design features, including material choice, taper design, and articular surface finish, are identical. Additionally, Biolox Delta Ceramic Femoral Heads in the same size range have previously been cleared for market via K082844.
Intended 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.
1
Summary of Safety and Effectiveness Biolox Delta Ceramic Femoral Heads Smith & Nephew, Inc.
Performance Data
Performance testing has been conducted for the subject devices in accordance with the guidance titled "Draft Guidance Document for Testing Non-articulating, 'Mechanically Locked,' Modular Implant Components," dated May 1, 1995, "Guidance Document for Testing Acetabular Cup Prostheses," dated May 1995, and "Draft Guidance for the Preparation of Premarket Notifications for Ceramic Ball Hip Systems", dated January 10, 1995. Range of motion, femoral head burst, femoral head fatigue, wear performance, assembly/disassembly strength, and head/stem construct fatigue have been evaluated. A review of the testing 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 device.
Substantial Equivalence Information
The subject Biolox Delta Ceramic Femoral Heads are substantially equivalent to the predicate devices listed in the table below. 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 femoral heads.
| Manufacturer | Description | Submission
Number | Clearance
Date |
|----------------------|------------------------------------|----------------------|-------------------|
| Smith & Nephew, Inc. | Biolox Delta Ceramic Femoral Heads | K083762 | 3/11/09 |
| Zimmer, Inc. | Biolox Delta Ceramic Femoral Heads | K071535 | 11/19/07 |
| Encore Medical, LP | Biolox Delta Ceramic Femoral Heads | K082844 | 11/25/08 |
Conclusion
As previously noted, this Traditional 510(k) Premarket Notification is being submitted to request clearance for the Biolox Delta Ceramic Femoral Heads. Based on the similarities to the predicate devices and a review of the testing, the devices are substantially equivalent to femoral head components currently marketed under K083762, K071535, and K082844.
2
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 eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle symbol. The logo is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Smith & Nephew, Inc. % Ms. Megan Bevill Regulatory Affairs Specialist 1450 Brooks Road Memphis, Tennessee 38116
MAY - 5 2010
Re: K100412
Trade/Device Name: Biolox Delta Ceramic Femoral Heads Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: II Product Code: LZO Dated: February 11, 2010 Received: February 16, 2010
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. 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
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Page 2 - Ms. Megan Bevill
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/ReportalProblem/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 yours.
Roubare bueniap
Mark N. Melke Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): 上口の412
Device Name: Biolox Delta Ceramic Femoral Heads
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 frauma or noninflammalory degenerative joint disease (NID) 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.
Prescription Use × (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)
Suta for mmm
(Division Sign-Off)
Division of Surgical, Orthol and Restorative Devic
510(k) Number K100412
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