(157 days)
Not Found
Not Found
No
The document describes a mechanical implant (acetabular shells) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a total hip component, which is indicated for individuals undergoing surgery to rehabilitate damaged hips caused by various conditions, functioning as a replacement or repair mechanism for a diseased or damaged body part.
No
The device description clearly states it is an acetabular shell used for hip replacement surgery, falling under the category of an implantable prosthetic device rather than a diagnostic tool.
No
The device description clearly indicates it is a physical implant (acetabular shells) used in hip surgery, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The provided text describes a total hip component, specifically acetabular shells, used in surgical procedures to replace damaged hip joints. This is an implantable device used directly within the body, not for testing samples outside the body.
The information clearly indicates a surgical implant for orthopedic use, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
Total hip components are indicated for individuals undergoing primary or 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 eiphysis, fused hip, fracture of the pelveis, and diastrophic variant; congenital dysplasia; 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 osteoeomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
HA Coated Reflection Acetabular Shells and HA Coated Reflection InterFit Acetabular Shells are for single use only and are intended for cementless fixation.
Product codes (comma separated list FDA assigned to the subject device)
MEH
Device Description
The Reflection acctabular shells are hemispherical in shape. Shells are available with and without holes. Multi-hole shells are designed to accommodate metallic cancellous screws. HA Reflection Acetabular Shells and HA Reflection InterFit Shells are used with existing Reflection UHMWPE liners.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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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.
Reflection Acetabular Shell - Smith & Nephew, Inc. Reflection InterFit Actebular Shell - Smith & Nephew, Inc. Osteonics SecurFit HA Hydroxylapatite Coated Shell Osteonics Normalized AD-HA Acetabular Component System Osteonics HA Generation II Acctabular component System Osteonics Restoration HA Hip Stems APR Porous HA Hip Stem - Sulzar Orthopedics, Inc.
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
Standards Data Form for Abbreviated 510(k)s
510(k) Number:
| Standard Organization No: | ASTM |
|---|---|
| Standard Identification No: | F1472, F67 |
| CDRH Internal Reference No: | 433, 411 |
Comment: These two ASTM standards are materials' specification only.
| Declaration of Conformity Elements: | |||
|---|---|---|---|
| Any Adaptations Applied | yes | no | x |
| Any Requirements Not Applicable | yes | no | x |
| Any Deviations Applied | yes | no | x |
| Any Differences in Device Tested and Finished Product | yes | no | x |
| *Is There a Third Party or Test Lab Involved | yes | no | x |
Was there another standard used in the review of this submission? yes no X
If another standard was used, please fill out an additional form.
- This is not the third party that reviews 510ks
1
510(k) Summary Hyaroxyapatite (HA) Coated Reflection® Acetabular Shell Hydroxyapatite (HA) Coated Reflection InterFit® Shell
Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared: Trade or proprietary device name: Smith & Nephew. Inc.. Orthopaedic Division 1450 Brooks Road, Memphis, TN 38116 901/399-5153 Janet Johnson Green February 26, 1999 HA Coated Reflection Acetabular Shell HA Coated Reflection InterFit Shell
Common or usual name: Classification name:
Acetabular Shell Title 21 CFR 888.3358 Hip joint metal/ polymer/ metal, semi-onstrained porous-coated uncemented prosthesis
Device Product Code and Panel Code: 87MEH - Panel: Orthopaedics/87
Substantially Equivalent, Legally Marketed Predicate Devices: Reflection Acetabular Shell - Smith & Nephew, Inc. Reflection InterFit Actebular Shell - Smith & Nephew, Inc. Osteonics® SecurFit™HA Hydroxylapatite Coated Shell Osteonics® Normalized AD-HA Acetabular Component System Osteonics® HA Generation II Acctabular component System Osteonics® Restoration HA Hip Stems APR Porous HA Hip Stem - Sulzar Orthopedics, Inc.
Subject device description:
The Reflection acctabular shells are hemispherical in shape. Shells are available with and without holes. Multi-hole shells are designed to accommodate metallic cancellous screws. HA Reflection Acetabular Shells and HA Reflection InterFit Shells are used with existing Reflection UHMWPE liners.
Subject device intended use:
Total hip components are indicated for individuals undergoing primary or 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 eiphysis, fused hip, fracture of the pelveis, and diastrophic variant; congenital dysplasia; 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 osteoeomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
HA Coated Reflection Acetabular Shells and HA Coated Reflection InterFit Acetabular Shells are for single use only and are intended for cementless fixation.
Technolocgical Characteristics:
HA Reflection Acetabular Shells and HA Reflection InterFit Acetabular Shells are sinilar to legally marketed devices listed above in that all of these devices are indicated for total hip replacement, are manufactured from similar or like materials, and are similar in technological characteristics. Performance characteristics:
Data indicate that HA Reflection Acetabular Shells and HA Reflection InterFit Acetabular Shells are substantially equivalent to predicate devices.
2
AUG -6 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Trude C. McLean Sr. Regulatory Affairs Specialist Smith & Nephew, Incorporated 1450 Brooks Road Memphis, Tennessee 38116
Re: K990666
Trade Name: Hydroxyapatite Reflection® Acetabular Shells Regulatory Class: II Product Code: MEH Dated: May 28, 1999 Received: June 2, 1999
Dear Ms. McLean:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
3
Page 2 – Ms. Trude C. McLean
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS STATEMENT
HA Coated Reflection® Acetabular Shell HA Coated Reflection InterFit® Acetabular Shell
Total hip components are indicated for individuals undergoing primary or 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 eiphysis, fused hip, fracture of the pelvcis, and diastrophic variant; congenital dysplasia; old, remote osteomyelitis with an extended drainagefree period, nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteoeomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity.
bcoee
Prescription Use
(Per 21 CFR 801.109) X