510(k) Report

510(k) · Cleared

Cleared

Whiteside Biomechanics Spinal System

K991678510(k) TraditionalCleared Aug 12, 199987-day reviewClass II21 CFR 888.3060

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Whiteside Biomechanics, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Aug 12, 1999 as substantially equivalent to K973425 (Corin USA, 1998) after an 87-day review. Its family tree reaches back 1 generation to 1998.

Decided
Aug 12, 1999
Review
87 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K973425 (1998). No later device cites it as a predicate yet.

K973425 · The Mehdian Lumbo-Sacral Pedicle Screw System · Corin USA · 1998199619982000
K973425 · The Mehdian Lumbo-Sacral Pedicle Screw System · Corin USA · 19980
  1. Root · 1 generation backK973425 The Mehdian Lumbo-Sacral Pedicle Screw SystemCorin USA · 1998
  2. This deviceK991678 Whiteside Biomechanics Spinal SystemWhiteside Biomechanics, Inc. · 1999
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K973425The Mehdian Lumbo-Sacral Pedicle Screw SystemCorin USA1998—
0 (this device)K991678Whiteside Biomechanics Spinal SystemWhiteside Biomechanics, Inc.1999—
FIG. 1 — Lineage of K991678, 1998–1999Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K973425The Mehdian Lumbo-Sacral Pedicle Screw System
Summary page 1
…nal System Spinal Intervertebral Body Fixation Orthosis Spinal Interlaminal Fixation Orthosis Spondylolisthesis Spinal Fixation Device System The Corin Spinal System (K973425) A spinal system consisting of screws, hooks, washers, spacer and plates/screws. The pedicle screws are available in four diamet…
Corin USA1998—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

1.) The device system consisting of pedicle screws, washers, spacers, utilizing the anterolateral/anterior surgical approach is intended for the following uses: a.) Anterolateral screw fixation to the non-cervical spine, b.) Anterior screw fixation to the cervical spine. The anterolateral/anterior system is intended for use in the following indications: a.) Degenerative disc disease of the lumbar, thoracic and cervical spine relating to discogenic origin…

Read the full statement (294 words)

1.) The device system consisting of pedicle screws, washers, spacers, utilizing the anterolateral/anterior surgical approach is intended for the following uses:

a.) Anterolateral screw fixation to the non-cervical spine,

b.) Anterior screw fixation to the cervical spine.

The anterolateral/anterior system is intended for use in the following indications:

a.) Degenerative disc disease of the lumbar, thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.

b.) Spondylolisthesis

c.) Trauma

d.) Spinal Stenosis

e.) Scoliosis

f.) Kyphosis

g.) Tumor

h.) Pseudoarthrosis

i.) Previous failed fusion

2.) The device system consisting of hooks, screws, washers, spacer, when utilized as a non-pedicle posterior system is intended for use in the following:

a.) Hook and sacral/iliac screw fixation to the non-cervical spine.

The non-pedicle posterior system is intended for use in the following indications:

a.) Degenerative disc disease of the lumbar, thoracic and cervical spine relating to discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies.

b.) Spondylolisthesis

c.) Trauma

d.) Spinal Stenosis

e.) Scoliosis

f.) Kyphosis

g.) Tumor

h.) Pseudoarthrosis

i.) Previous failed fusion

3.) The device system of hooks, spacers, sacral/iliac screws and pedicle screws is intended for patients:

a.) Having a severe spondylolisthesis (grades 3 and 4) at the L5-S1 joint:

b.) Who are receiving fusions using autogenous bone graft only:

c.) Who are having the device fixed or attached to the lumbar and sacral spine: and

d.) Who are having the device removed after the development of a solid fusion mass.

The levels of pedicle screws fixation are limited to L3-S1.

The devices are manufactured from Titanium Alloy: ASTM F138 or Stainless Steel: ASTM F1472-93. Only components manufactured from the same material may be used in combination.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Whiteside Biomechanics, Inc.

13 FDA decisions under this applicant name. See the company

  • K033313Quatro M Femoral ComponentWhiteside Biomechanics, Inc. · 2004
  • K012800Symmetric Unicompartmental Knee SystemWhiteside Biomechanics, Inc. · 2002
  • K003618Whiteside Biomechanics Low Profile Stainless Steel Cable System, Model Bio-1-1014Whiteside Biomechanics, Inc. · 2001
  • K993903Whiteside Biomechanics Titanium Low-Profile Cable, Model Bio-1-1013Whiteside Biomechanics, Inc. · 2000
  • K981238Bipolar Femoral HeadWhiteside Biomechanics, Inc. · 1998

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https://510kreport.com/device/K991678 · printed Nov 4, 2026

Cite this page

510(k) Report. “K991678: Whiteside Biomechanics Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991678

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026