(83 days)
Not Found
No
The summary describes a ceramic femoral head for hip replacement, a purely mechanical device. There is no mention of software, algorithms, or any technology that would incorporate AI or ML.
Yes
The device is a component of a total hip replacement, which is indicated for individuals undergoing primary and revision surgery to rehabilitate hips damaged by various conditions. This directly aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The provided text describes a medical implant (total hip components/femoral heads) used for treatment/rehabilitation, not for diagnosing a condition.
No
The device description clearly states it is a ceramic femoral head, which is a physical implantable component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The provided text describes a total hip component, specifically a ceramic femoral head. This is a surgical implant designed to be placed inside the human body to replace a damaged hip joint.
- Intended Use: The intended use clearly states it's for individuals undergoing primary and revision surgery to rehabilitate damaged hips. This is a surgical procedure, not a diagnostic test performed on a specimen outside the body.
The device is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Total 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, inflammatory joint disease such as rheumatoid arthritis; or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthrifis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; 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. The Biolox Delta Ceramic femoral heads are for single use only.
Product codes (comma separated list FDA assigned to the subject device)
LZO
Device Description
The Biolox Delta Ceramic femoral heads feature a 12/14 taper and are intended to be used with existing Smith & Nephew femoral hip stems. The ceramic femoral head mechanically locks with the femoral hip stem via a taper junction and articulates against a Smith & Nephew polyethylene acetabular liner. The subject devices are similar in design and function to the Biolox Forte Alumina Ceramic femoral heads cleared via 510(k) premarket notifications K981847, K991162, and K022958 respectively.
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)
Mechanical Testing: A review of the mechanical data indicated that the Smith & Nephew Biolox Delta Ceramic femoral heads are equivalent to devices currently cleared for market and are capable of withstanding expected in vivo loading without failure.
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.
K981847, K991162, K022958, K071535
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
Summary of Safety and Effectiveness for Summary of Salety and Enectiveness for
Smith & Nephew Biolox Delta Ceramic Femoral Heads
Contact Person and Address
Date of Summary: August 27, 2008
Mandy L. Coe Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116 (901) 399-6277
Name of Device: Smith & Nephew Biolox Delta Ceramic Femoral Heads Common Name: Femoral Head Device Classification: 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis - Class II Device Product Code: LZO
Device Description
The Biolox Delta Ceramic femoral heads feature a 12/14 taper and are intended to be used with existing Smith & Nephew femoral hip stems. The ceramic femoral head mechanically locks with the femoral hip stem via a taper junction and articulates against a Smith & Nephew polyethylene acetabular liner. The subject devices are similar in design and function to the Biolox Forte Alumina Ceramic femoral heads cleared via 510(k) premarket notifications K981847, K991162, and K022958 respectively.
Mechanical Testing
A review of the mechanical data indicated that the Smith & Nephew Biolox Delta Ceramic femoral heads are equivalent to devices currently cleared for market and are capable of withstanding expected in vivo loading without failure.
Intended Use
Total 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, inflammatory joint disease such as rheumatoid arthritis; or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthrifis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; 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. The Biolox Delta Ceramic femoral heads are for single use only.
Substantial Equivalence Information
The Smith & Nephew Biolox Delta Ceramic femoral heads are similar in overall design, material and indications to the Smith & Nephew Biolox Forte Alumina Ceramic femoral heads cleared via 510(k) premarket notifications K981847, K991162, and K022958 as well as the Zimmer Biolox Delta Ceramic femoral heads cleared via K071535.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle.
MAR 1 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Smith & Nephew, Inc. % Ms. Mandy Coe Regulatory Affairs Specialist 1450 E. Brooks Road -Memphis, Tennessee 38116
Re: K083762
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
Regulation Class: Class II
Product Code: LZO
Dated: February 27, 2009 Received: March 2, 2009
Dear Ms. Coe:
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 such 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); good manufacturing practice requirements as set
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Page 2 -- Ms. Mandy Coe
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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
L. Arimid. for
Mark N. Melkerson Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K083762
Device Name: Biolox Delta Ceramic Femoral Heads
Indications for Use:
Total 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, 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; old, remote osteomvelitis with an extended drainage-free period; 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 Biolox Delta Ceramic femoral heads are for single use only.
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) SIVISION SIDU-1 · Vivision of General, Restorative nd Neurological Devices
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Indications