Product Code: KTW
FDA class 2
21 CFR 888.3030
Appliance, Fixation, Nail/Blade/Plate Combination, Single Component
Orthopedic
The Single Component Nail/Blade/Plate Combination Fixation Appliance is a one-piece orthopedic implant used to internally stabilize fractures of the proximal femur and hip region, supporting bone alignment and healing without the need for multiple assembled parts. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification before marketing. The product code is KTW, regulated under 21 CFR 888.3030, in the Orthopedic medical specialty. This device is an implant.
510(k)s
38
FEI Numbers
48
Registration Numbers
48
Unique Applicants
26
Years Active
40
Basic Information
- Product Code
- KTW
- Device Class
- FDA class 2
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Review Panel
- OR
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✓
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 38 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K182285 | PK High Tibial Osteotomy Correction System | Jun 20, 2019 | Substantially Equivalent | Paonan Biotech Co., Ltd. |
| K171606 | AOS Anterolateral Proximal Humeral Plate | Jun 22, 2017 | Substantially Equivalent | Advanced Orthopaedic Solutions, Inc. (AOS) |
| K170693 | Phantom Small Bone Intramedullary Nail System | Jun 19, 2017 | Substantially Equivalent | Paragon 28, Inc. |
| K160409 | AOS Anterolateral Proximal Humeral Plate | Mar 15, 2016 | Substantially Equivalent | ADVANCED ORTHOPAEDIC SOLUTIONS, INC |
| K122541 | ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP) | Sep 20, 2012 | Substantially Equivalent | ORTHOFIX SRL |
| K080590 | AOS PROXIMAL HUMERAL PLATE | May 06, 2008 | Substantially Equivalent | ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
| K080109 | SYNTHES (USA) MODULAR BLADE PLATE SYSTEM | Mar 20, 2008 | Substantially Equivalent | SYNTHES (USA) |
| K062920 | ORTHOFIX TITANIUM HUMERAL PLATING SYSTEM LSP | Nov 13, 2006 | Substantially Equivalent | ORTHOFIX SRL |
| K023360 | LEFORTE SYSTEM BONE PLATE | Oct 25, 2002 | Substantially Equivalent | JEIL MEDICAL CORPORATION |
| K012645 | REPROCESSED EBI EXTERNAL FIXATION DEVICES | Jun 24, 2002 | Substantially Equivalent | ALLIANCE MEDICAL CORP. |
| K012634 | REPROCESSED EXTERNAL FIXATION DEVICE | Jun 24, 2002 | Substantially Equivalent | ALLIANCE MEDICAL, INC. |
| K011815 | SYNTHES LCP PROXIMAL HUMERUS PLATES | Sep 06, 2001 | Substantially Equivalent | SYNTHES (USA) |
| K011458 | SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM | Aug 02, 2001 | Substantially Equivalent | SYNTHES (USA) |
| K010321 | MODULAR FOOT SYSTEM - 2.7 MM MODULE | May 02, 2001 | Substantially Equivalent | SYNTHES (USA) |
| K001614 | STRYKER TRAUMA PELVIC SET | Aug 04, 2000 | Substantially Equivalent | HOWMEDICA OSTEONICS CORP. |
| K001271 | SAMARCO SPIDER PLATES | Jul 14, 2000 | Substantially Equivalent | BIOMET, INC. |
| K992837 | 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP) | Oct 25, 1999 | Substantially Equivalent | SYNTHES (USA) |
| K991405 | OMNI-FIX, HUMERAL NAIL | Jun 29, 1999 | Substantially Equivalent | TURNKEY INTERGRATION USA, INC. |
| K990307 | OMNI-FIX, NAIL SYSTEM | Apr 01, 1999 | Substantially Equivalent | TURNKEY INTERGRATION USA, INC. |
| K982390 | CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE) | Sep 14, 1998 | Substantially Equivalent | WRIGHT MEDICAL TECHNOLOGY, INC. |
| K971272 | TRAUMA-FIX EXTERNAL FIXATOR | Jun 05, 1997 | Substantially Equivalent | TREND MEDICAL, INC. |
| K954289 | SYNTHES CANNULATED ANGLE BLADE PLATE | Nov 24, 1995 | Substantially Equivalent | SYNTHES (USA) |
| K931686 | MALLEOLAR SCREW | Apr 05, 1994 | Substantially Equivalent | ONYX MEDICAL CORP. |
| K925635 | TORUS EXTERNAL FIXATION SYSTEM | Jun 01, 1993 | Substantially Equivalent | ZIMMER, INC. |
| K924657 | TRUE/FLEX METATARSAL RODS | Nov 24, 1992 | Substantially Equivalent | APPLIED OSTEO SYSTEMS, INC. |
| K914546 | ANGLED BLADE PLATE | Nov 29, 1991 | Substantially Equivalent for Some Indications | SYNTHES (USA) |
| K905348 | HANSEN-STREET TYPE INTRAMEDULLARY NAIL | Dec 11, 1990 | Substantially Equivalent | O'TEC CORP. |
| K893928 | LEVTECH SMALL BONE PLATE | Nov 03, 1989 | Substantially Equivalent | BUCKMAN CO., INC. |
| K870727 | WARSAW ORTHOPEDIC I BONE PLATE | Mar 09, 1987 | Substantially Equivalent | WARSAW ORTHOPEDIC, INC. |
| K862552 | ACROMED ADS BONE NAIL | Sep 02, 1986 | Substantially Equivalent | BUCKMAN CO., INC. |
| K862279 | EXPENDAGUIDE MULTIPLE HIP PINNING GUIDE SYSTEM | Jul 25, 1986 | Substantially Equivalent | ORTHOSPEC, INC. |
| K851349 | LERE NAIL & PLATE COMBIN. ONE PIECE FORGED | May 29, 1985 | Substantially Equivalent | MEDICALEX |
| K843554 | BONE SCREWS | Oct 01, 1984 | Substantially Equivalent | MECRON MEDICAL PRODUCTS, INC. |
| K843553 | BONE PLATES | Oct 01, 1984 | Substantially Equivalent | MECRON MEDICAL PRODUCTS, INC. |
| K821566 | ORTHOPEDIC FIXATION DEVICES | Jun 03, 1982 | Substantially Equivalent | HOWMEDICA CORP. |
| K813340 | HIP PIN | Jan 29, 1982 | Substantially Equivalent | THE DECA CO. |
| K792291 | SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES | Dec 06, 1979 | Substantially Equivalent | SYNTHES (USA) |
| K781762 | COMPRESSION HIP SCREW SYSTEM | Dec 20, 1978 | Substantially Equivalent | HOWMEDICA CORP. |
FEI Numbers
This FDA classification entry is associated with 48 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 48 registration numbers. Click on an entry to view related FDA registrations.