(113 days)
No
The document describes a mechanical hip implant system and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is a femoral stem implanted to treat various degenerative joint diseases and fractures, which falls under the definition of a therapeutic device designed to alleviate or cure a condition.
No
The device, Balance Hip System Femoral stems, is described as an implant used for hip replacement and correction of deformities and fractures, not for diagnosing medical conditions.
No
The device description clearly describes physical femoral stems, which are hardware components, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The provided text describes a femoral stem, which is an implantable medical device used in hip replacement surgery. Its intended use is to treat various conditions affecting the hip joint by replacing the damaged part of the femur.
- Lack of Specimen Analysis: There is no mention of this device being used to analyze any biological specimens. Its function is purely mechanical and structural within the body.
Therefore, based on the provided information, the Balance® Hip System Femoral stems are not IVD devices. They are surgical implants.
N/A
Intended Use / Indications for Use
Balance® Hip System Standard Femoral stems
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Correction of functional deformity
- Correction of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty.
The Balance® Hip System Standard Femoral stems are intended for uncemented use only.
Balance® Hip System Microplasty® stems
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Correction of functional deformity
- Correction of non-union, femoral neck fracture, and trochanteric fractures of the Proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed femoral head resurfacing component.
The Balance® Hip System Microplasty® stems are intended for uncemented use only.
Specific indications for compatible components that can be used with the above femoral stems include:
Constrained Liners (K030047): Constrained liners are intended for general use in skeletally mature individuals undergoing revision surgery at high risk of intra-operative instability and for whom all other options to constrained acetabular components have been considered.
OSS / Salvage Systems / Total Femur (K974558, K002757, K021380, K033871): Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, unsuccessful osteotomy or arthrodesis.
Interlocking Stems (K990830, K042774): Interlocking hip stems are indicated for non-cemented application in cases of revision, fracture, oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
Product codes (comma separated list FDA assigned to the subject device)
KWZ, JDL, KWA, JDI, LZO, MEH, LPH, LZY, KWY
Device Description
The Balance® Hip System Femoral stems are collarless, porous coated stems available in both Standard and Micropilasy - Stein Teligaal Tilling of the metaphysis and provide immediate three point (anterior-proximal, inferior-medial, and distal-lateral) fixation. The top of the stems have a threaded hole to accommodate the inserter / extractor tool.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hip joint, proximal femur
Indicated Patient Age Range
skeletally mature individuals
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)
Non-Clinical Testing: Reference literature and performance data demonstrate that the Balance® Hip is Technically equivalent to the predicate femoral hip stems.
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.
K921181, K030055, K943230, K921224
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.
K030047, K974558, K002757, K021380, K033871, K990830, K042774
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
§ 888.3330 Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis.
(a)
Identification. A hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis is a two-part 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 includes prostheses that consist of a femoral and an acetabular component, both made of alloys, such as cobalt-chromium-molybdenum. The femoral component is intended to be fixed with bone cement. The acetabular component is intended for use without bone cement (§ 888.3027).(b)
Classification. Class III.(c)
Date PMA or notice of completion of PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 18, 2016, for any hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976, or that has, on or before May 18, 2016, been found to be substantially equivalent to a hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component that was in commercial distribution before May 28, 1976. Any other hip joint metal/metal semi-constrained prosthesis with an uncemented acetabular component shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
MAY 27 2005 K050251 P 1/2
510(k) Summary
| Applicant/Sponsor: | Biomet Manufacturing Corp.
56 East Bell Drive
P.O. Box 587
Warsaw, Indiana 46581-0587 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Gary Baker
Regulatory Specialist
Biomet Manufacturing Corp.
P.O. Box 587
Warsaw, Indiana 46581-0587
Phone: (574) 267-6639
FAX: (574) 372-1683 |
| Proprietary Name: | Balance ® Hip System |
| Common Name: | Femoral Hip Stems |
| Classification Name: | The Balance ® Hip System femoral stems and compatible shells, heads, and
liners included in this submission have the following classifications: |
- Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR §888.3310)
- Hip joint metal/metal semi-constrained, with a cemented acetabular component, prosthesis (21
- CFR §888.3320) 3. Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis (21 CFR §888.3330)
- (21 CFR 9886.3530)
Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR §888.3350) 4. - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis 5. (21 CFR §888.3353)
- (21 CFR 9666.3333)
Hip joint metal/polymer/metal semi-constrained, porous-coated, uncemented prosthesis (21 CFR 6. 888.3358)
176
1
KOSOGI 1 2/2
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Mallory - Head® Total Hip System - Biomet Inc. (K921181, K030055) Mayo Conservative Hip Prosthesis - Zimmer Inc. (K943230) Bi-Metric® Total Hip System - Biomet Inc. (K921224, K030055)
Device Description: The Balance® Hip System Femoral stems are collarless, porous coated stems available Device Description: The Dalance "The Bygths. The proximal geometry of the Balance" Hip System IN 00th Standard and Micropiasy - Stein Teligaal Tilling of the metaphysis and provide immediate three point (anterior-proximal, inferior-medial, and distal-lateral) fixation.
The top of the stems have a threaded hole to accommodate the inserter / extractor tool.
Indications for Use: Balance® Hip System Standard Femoral stems
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular 1 . necrosis.
- Rheumatoid arthritis 2.
- Correction of functional deformity 3.
- Correction of ranchenal developed neck fracture, and trochanteric fractures of the 4. proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed total hip arthroplasty. న్.
The Balance® Hip System Standard Femoral stems are intended for uncemented use only.
Indications for Use: Balance® Hip System Microplasty® stems
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular 1. necrosis.
- Rheumatoid arthritis 2.
- Correction of functional deformity 3.
- Corroon of non-union, femoral neck fracture, and trochanteric fractures of the 4. Proximal femur with head involvement, unmanageable using other techniques.
- Revision of previously failed femoral head resurfacing component. ર.
The Balance® Hip System Microplasty® stems are intended for uncemented use only.
Summary of Technologies: The Balance® Hip System stems are materials and utilize the Summal y of Technologics. The Datanoo Trip 55000 ses as the predicates. Testing determined that the stems are substantially equivalent to the predicate stems.
Reference literature and performance data demonstrate that the Balance® Hip Non-Clinical Testing: Nor Chilleur Technically equivalent to the predicate femoral hip stems.
All trademarks are property of Biomet, Inc.
2
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 features three abstract human figures connected by flowing lines. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 27 2003
Mr. Gary Baker Regulatory Specialist Biomet Incorporated P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K050251
Trade/Device Name: Balance® Hip System Microplasty® Stems Regulation Number: 21 CFR 888.3310, 888.3320, 888.3330, 888.3350, 888.3358 Regulation Name: Hip joint metal/polymer constrained cemented or uncemented prosthesis; Hip joint metal/metal semi constrained, with a cemented acetabular component, prosthesis; Hip joint metal/ polymer semi-constrained cemented prosthesis; Hip joint metal/polymer/metal semi-constrained porous-coated, uncemented prosthesis Regulatory Class: III Product Code: KWZ, JDL, KWA, JDI, LZO, MEH, LPH, LZY, KWY Dated: May 6, 2005 Received: May 9, 2005
Dear Mr. Baker:
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.
3
Page 2 - Mr. Gary Baker
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 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 Office of Compliance at (240) 276-0210. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
A. Stephen Purdy
Miriam C. Provost, Ph.D. Acting 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): K05025
Device Name: Balance Hip System Standard Femoral Stems
Indications for Use:
- ations for Use.
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
-
- Rheumatoid arthritis
-
- Correction of functional deformity
-
- Correction of non-union. femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
-
- Revision of previously failed total hip arthroplasty.
Balance® Hip System Femoral Stems are intended for uncemented use only.
Specific indications for compatible components that can be used with the above femoral stems include:
Constrained Liners (K030047)
Constrained liners are intended for general use in skeletally mature individuals undergrand in the bone loss, soft Constrained liners are mielided for general use in skelcians valistocation, joint or bose loss, soft revision surgery at high risk of intra-operative instability and for whom all other options to constrained acetabular components have been considered.
OSS / Salvage Systems / Total Femur (K974558. K002757. K021380. K033871)
Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, Salvage Oncology Trip and Total Pennal Virginian of unsuccessful osteotomy or arthrodesis.
Interlocking Stems (K990830, K042774)
Interlocking hip stens are indicated for non-cemented application in cases of revision, tracture, Interlocking mp siems are moreated for non econential.
oncology or other situations where severe proximal bone loss may compromise the fixation and stability of a standard type hip replacement prosthesis.
X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 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
tion (ODE)
Hypt Rurla
Image /page/4/Picture/25 description: The image shows handwritten text. The text on the right side of the image reads 'K050251'. The text on the left side of the image is partially visible and blurry, but it appears to be a word.
5
Indications For Use
510(k) Number (IF KNOWN): K050251
Device Name: Balance® Hip System Microplasty® Stems
Indications for Use:
-
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis 2.
- Correction of functional deformity 3.
- Correction of functional deformily
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur ব with head involvement, unmanageable using other techniques. - while it not on of previously failed femoral head resurfacing components. న్న
Balance & Hip System Microplasty Stems are intended for uncemented use only.
Specific indications for compatible components that can be used with the above femoral stems include:
Constrained Liners (K030047)
Constrained liners are intended for general use in skeletally mature individuals undergoung port on home loss, soft Constrained liners are mielided for general use in skercars non or brinn of bone loss, soft revision surgers at lightifisk of life distance date instability and for whom all other options to constrained acetabular components have been considered.
OSS / Salvage Systems / Total Femur (K974558, K002757, K021380, K033871)
Salvage/Oncology Hip and Total Femur components are also indicated for cases of ligament deficiency, Salvage Oneology Trip and Total ions insuccessful osteotomy or arthrodesis.
Interlocking Stems (K990830, K042774)
Interlocking hip stems are indicated for non-cemented application in cases of revision, tracture, Interlocking hip stems are indicated for non-centence approamer the fixation and stability of a standard type hip replacement prosthesis.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 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)
(Division Sign-Off)
and Neurological Devices
510(k) Number kos0251