Whiteside Biomechanics, Inc.
Creve Coeur, MO, US
Whiteside Biomechanics, Inc. appears in FDA device records in Creve Coeur, MO. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Whiteside Biomechanics, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Signal Medical Corporation510(k), enforcement report, recall
510(k) clearance history
FDA records hold 24 510(k) clearances for Whiteside Biomechanics, Inc. between 1996 and 2021. The busiest year on record is 1997, with 6. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1996 | 3 |
| 1997 | 6 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 3 |
| 2004 | 1 |
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 2 |
| 2011 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K203779 | Symmetric Total Knee System | MBH | Substantially Equivalent | |
| K100370 | SYMMETRIC TOTAL KNEE AGUMENTS | JWH | Substantially Equivalent | |
| K080199 | SYMMETRIC TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | |
| K073674 | BONE FIXATION WIRE (KIRSCHNER WIRE) | HTY | Substantially Equivalent | |
| K051510 | SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM | MBH | Substantially Equivalent | |
| K043289 | E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOT | KTT | Substantially Equivalent | |
| K033313 | QUATRO M FEMORAL COMPONENT | LWJ | Substantially Equivalent | |
| K022382 | RHS ACETABULAR COMPONENT | LPH | Substantially Equivalent | |
| K021063 | GREAT TOE IMPLANT | KWD | Substantially Equivalent | |
| K012800 | SYMMETRIC UNICOMPARTMENTAL KNEE SYSTEM | HRY | Substantially Equivalent | |
| K003618 | WHITESIDE BIOMECHANICS LOW PROFILE STAINLESS STEEL CABLE SYSTEM, MODEL BIO-1-1014 | NDD | Substantially Equivalent | |
| K993903 | WHITESIDE BIOMECHANICS TITANIUM LOW-PROFILE CABLE, MODEL BIO-1-1013 | JDQ | Substantially Equivalent | |
| K991678 | WHITESIDE BIOMECHANICS SPINAL SYSTEM | KWQ | Substantially Equivalent | |
| K981238 | BIPOLAR FEMORAL HEAD | KWY | Substantially Equivalent | |
| K981302 | SMC 28MM CERAMIC FEMORAL HEADS | LZO | Substantially Equivalent | |
| K971681 | SMC FEMORAL HIP COMPONENT | JDI | Substantially Equivalent | |
| K973261 | WHITESIDE BIOMECHANICS, INC. CERAMIC UNIPOLAR FEMORAL HEAD | LZO | Substantially Equivalent | |
| K971018 | SMC ACETABULAR COMPONENT | LPH | Substantially Equivalent | |
| K964616 | QUATROLOC PLASMA SPRAYED FEMORAL COMPONENT | LPH | Substantially Equivalent | |
| K971721 | WHITESIDE BIOMECHANICS, INC. ZIRCONIA CERAMIC FEMORAL HEAD | LZO | Substantially Equivalent | |
| K971718 | MICRO-SEAL ACETABULAR SYSTEM | LPH | Substantially Equivalent | |
| K964150 | WHITESIDE BIOMECHANICS ZIRCONIA CERAMIC FEMORAL HEAD | LZO | Substantially Equivalent | |
| K961625 | QUATROLOC FEMORAL COMPONENT & HEAD | LPH | Substantially Equivalent | |
| K961157 | WHITESIDE BIOMECHANICS CANCELLOUS BONE SCREW | HWC | Substantially Equivalent for Some Indications |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
- KWQAppliance, Fixation, Spinal Intervertebral Body
- JDQCerclage, Fixation
- NDDCerclage, Fixation, Metallic
- HTYPin, Fixation, Smooth
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- LWJProsthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- MBHProsthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- KWDProsthesis, Toe, Hemi-, Phalangeal
- HWCScrew, Fixation, Bone
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1834-2017 | Soft Face "No Bounce" Mallet Model/Catalog: BIO-1-1090 | Potential for poly tip of the mallet to come off during use. Potential for foreign material in the surgical field or delay in surgery. Reminder for customers that the poly tip must be removed for cleaning and sterilization to assure proper cleaning and sterilization of the entire mallet. | Class II | Terminated | |
| Z-0111-2015 | Symmetric Total Knee Femoral Components Product Usage: Symmetric Total Knee Femoral Component is intended for use with Signal Medical Corp. Total Knee System for cemented use INA Total Knee Replacement. The femoral component is made of cobalt chromium alloy (ASTM F75). | Packaging of a device was compromised | Class II | Terminated | |
| Z-0109-2015 | Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement. | Incorrect dimension on four liners was detected | Class II | Terminated | |
| Z-0316-2007 | Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and Posterior Acetabular Retractor-Right with Light Cord Bracket, Model #BIO-1-1051-A, packaged 1 retractor (left or right retractor) per plastic bag. The firm name on the label is Whiteside Biomechanics, Inc., St. Louis, MO. | The soft tissue pin in the retractor can break off and become embedded in the tissue. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain