(27 days)
K9640094, K9906661, K002747
No
The document describes a traditional orthopedic implant system (acetabular shells and liners) and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes.
The device is indicated for individuals undergoing primary and revision surgery to rehabilitate hips damaged due to various conditions like trauma, inflammatory joint disease, and degenerative joint disease. It aims to restore function and alleviate symptoms, which is a therapeutic purpose.
No
The device description indicates that the REFLECTION 3 Acetabular System consists of acetabular shells and liners manufactured from titanium alloy and XLPE, respectively. Its intended use is for individuals undergoing primary and revision surgery to rehabilitate damaged hips, which points to it being a surgical implant or prosthetic, not a diagnostic tool.
No
The device description explicitly states that the system consists of physical components (acetabular shells and liners made of titanium alloy and XLPE), indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for replacing damaged hip joints. This is a therapeutic device, not a diagnostic one.
- Device Description: The device is described as acetabular shells and liners made of titanium alloy and XLPE. These are physical components for surgical implantation.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The REFLECTION 3 Acetabular System is 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 theumatoid arthitis, or noninflammatory degenerative joint disease.(NIDJD) or any of its composite diagnoses such as osteoarthritis; avasular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-unton; 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 REFLECTION 3 Acetabular System is for single use only. The REFLECTION 3 Acetabular System is intended for cementless use.
Product codes (comma separated list FDA assigned to the subject device)
MBL
Device Description
The REFLECTION 3 Acetabular System consists of acetabular shells and liners. The REFLECTION 3 Shells are manufactured from titanium alloy. The REFLECTION 3 liners are manufactured from XLPE. The design of the shells and liners are similar to the REFLECTION Acetabular Shell, the REFLECTION Interfit Shell, and the 10MRad REFLECTION Acetabular Liner.
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.
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.
K9640094, K9906661, K002747
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
K061253 (pg 1 of 2)
SMITH & NEPHEW REFLECTION 3 ACETABULAR SYSTEM
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 901-399-5778 Katle Logerot May 2, 2006 REFLECTION 3 Acetabular System Hip Stem 21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis - Class II Class II Orthopedics/87/MBL
DEVICE CLASS: PRODUCT CODE:
DEVICE INFORMATION:
A. INTENDED USE:
The REFLECTION 3 Acetabular System is 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 theumatoid arthitis, or noninflammatory degenerative joint disease.(NIDJD) or any of its composite diagnoses such as osteoarthritis; avasular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-unton; 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 REFLECTION 3 Acetabular System is for single use only. The REFLECTION 3 Acetabular System is intended for cementless use.
B. DEVICE DESCRIPTION:
The REFLECTION 3 Acetabular System consists of acetabular shells and liners. The REFLECTION 3 Shells are manufactured from titanium alloy. The REFLECTION 3 liners are manufactured from XLPE. The design of the shells and liners are similar to the REFLECTION Acetabular Shell, the REFLECTION Interfit Shell, and the 10MRad REFLECTION Acetabular Liner.
C. SUBSTANTIAL EQUIVALENCE INFORMATION:
The substantial equivalence of the REFLECTION 3 Acetabular System is supported by its similartties in design features, overall indications, and material composition to the RELFECTION Acetabular System (K920430, K932755, K990666), the REFLECTION Interfit Shell (K9640094, K990666), and the DMRad REFLECTION Acetabular Liner (K002747) manufactured and distributed by Smith & Nephew, Inc.
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SUMMARY OF TECHNOLOGICAL COMPARISON: ن
The intended use, design, and materials of the REFLECTION 3 Acetabular System are substantially equivalent to the RELFECTION Acetabular System (K920430, K932755, K990666), the REFLECTION Interfit Shell IK9640094, K9906661, and the 10MRad REFLECTION Acetabular Liner (K002747). Design Control Activities have been completed and the results indicate that the subject device is safe and effective.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged in a circular fashion around the symbol. The caduceus is depicted in black, and the text is also in black against a white background.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 3 1 2006
Smith & Nephew, Inc. c/o Ms. Katie Logerot Regulatory Affairs Specialist II Orthopedic Division 1450 E. Brooks Road Memphis, Tennessee 38116
Re: K061253
Trade/Device Name: REFLECTION 3 Acetabular System 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: May 3, 2006
Received: May 4, 2006
Dear Ms. Logerot:
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
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Page 2 - Ms. Katie Logerot
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,
Hubert Semer wo
/ Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K061253
Device Name: REFLECTION 3 Acetabular System
Indications for Use:
The REFLECTION 3 Acelabular System is 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 meumatoid adhritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avasular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis and diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; non-union; 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 REFLECTION 3 Acetabular System is for single use only. The REFLECTION 3 Acetabular System is intended for cementless use.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
IPLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDEDI
Concurrence of CDRH, Office of Device Evaluation (ODE)
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510(k) Number_
Indications11.doc