510(k) Report

510(k) · Cleared

Cleared

Summit Occipito-Cervico-Thoracic (Oct) Spinal System

K002733510(k) TraditionalCleared Dec 15, 2000105-day reviewClass II21 CFR 888.3050

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

Depuyacromed · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Dec 15, 2000 as substantially equivalent to K965221 (Surgicraft, Ltd., 1997) and 6 other predicates after a 105-day review. Its family tree reaches back 3 generations to 1985. 2 of the 680 devices in its family, counting itself, have a Class I recall. 671 later devices descend from it.

Decided
Dec 15, 2000
Review
105 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
7

Its longest line of descent runs back 3 generations to K853033 (1985). 8 ancestors in all. 671 later devices descend from it, 16 citing it directly. 2 of the 680 devices in this family, counting this one, have a Class I recall.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor1999: 4 other ancestors2004: 4 descendants cleared2005: 3 descendants cleared2019: 32 descendants cleared2008: 14 descendants cleared2013: 31 descendants cleared2007: 8 descendants cleared2003: 2 descendants cleared2012: 29 descendants cleared2006: 4 descendants cleared2002: 1 descendant cleared2010: 13 descendants cleared, 1 with a Class I recall12001: 1 descendant cleared2018: 38 descendants cleared2011: 15 descendants cleared2009: 10 descendants cleared2014: 31 descendants cleared2015: 38 descendants cleared2017: 37 descendants cleared2020: 38 descendants cleared2021: 33 descendants cleared, 1 with a Class I recall12022: 38 descendants cleared2016: 29 descendants cleared2023: 66 descendants cleared2025: 50 descendants cleared2024: 57 descendants cleared2026: 49 descendants clearedK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 19981990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 5 other ancestors 1 generation forward: 16 descendants2 generations forward: 59 descendants3 generations forward: 87 descendants, 1 with a Class I recall14 generations forward: 113 descendants, 1 with a Class I recall15 generations forward: 116 descendants6 generations forward: 114 descendants7 generations forward: 69 descendants8 generations forward: 34 descendants9 generations forward: 28 descendants10 generations forward: 18 descendants11 generations forward: 11 descendants12 generations forward: 6 descendants K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 19850+5+10
  1. Root · 3 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 2 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 1 generation backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. This deviceK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. Descendant · cites it directly · 660 of its ownK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. Descendant · cites it directly · 659 of its ownK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. Descendant · cites it directly · 658 of its ownK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. Descendant · cites it directly · 657 of its ownK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. Descendant · 2 generations on · 490 of its ownK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006

Showing 5 of 671 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 22004: 42005: 32006: 42007: 82008: 142009: 102010: 132011: 152012: 292013: 312014: 312015: 382016: 292017: 372018: 382019: 322020: 382021: 332022: 382023: 662024: 572025: 502026: 49
2001high 66 (2023) · low 1 (2001)2026

Class I recalls in this family

  • K093670 Modification to: Oasys System3 generations on · 2010
  • K211616 ExcelsiusHub4 generations on · 2021

Most influential descendants

Showing 5 of 671 · See all
  • K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001 · cites it directly660descendants
  • K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002 · cites it directly659descendants
  • K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003 · cites it directly658descendants
  • K041203Summit Oct Spinal SystemDepuy Spine, Inc. · 2004 · cites it directly657descendants
  • K062174Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006 · 2 generations on490descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−2K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−1K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
0 (this device)K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
+1K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
+1K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
+1K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
+1K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
+2K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199940
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200320
200440
200530
200640
200780
2008140
2009100
2010131
2011150
2012290
2013310
2014310
2015380
2016290
2017370
2018380
2019320
2020380
2021331
2022380
2023660
2024570
2025500
2026490
FIG. 1 — Lineage of K002733, 1985–2026Source: 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.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (7)

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
*K965221Ransford Cervical Fixation System
Summary page 1
…000 Appliance, Fixation, Spinal Interlaminal Orthosis, Spinal Pedicle Fixation Summit Occipito-Cervico-Thoracic (OCT) Spinal System Ransford Cervical Fixation System (K965221) Synthes CerviFix System (K982322, K984377, K990965, K991089, K994187, K001864) When intended to promote fusion of the cervical…
Surgicraft, Ltd.1997—
*K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook System
Summary page 1
…nterlaminal Orthosis, Spinal Pedicle Fixation Summit Occipito-Cervico-Thoracic (OCT) Spinal System Ransford Cervical Fixation System (K965221) Synthes CerviFix System (K982322, K984377, K990965, K991089, K994187, K001864) When intended to promote fusion of the cervical spine and occipito-cervico-thoraci…
Synthes (Usa)1998—
*K984377Synthes Spine Cervifix System
Summary page 1
…al Orthosis, Spinal Pedicle Fixation Summit Occipito-Cervico-Thoracic (OCT) Spinal System Ransford Cervical Fixation System (K965221) Synthes CerviFix System (K982322, K984377, K990965, K991089, K994187, K001864) When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junctio…
Synthes (Usa)1999—
*K990965Synthes Cervifix System
Summary page 1
…is, Spinal Pedicle Fixation Summit Occipito-Cervico-Thoracic (OCT) Spinal System Ransford Cervical Fixation System (K965221) Synthes CerviFix System (K982322, K984377, K990965, K991089, K994187, K001864) When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occipu…
Synthes (Usa)1999—
*K991089Synthes Cervifix System
Summary page 1
…l Pedicle Fixation Summit Occipito-Cervico-Thoracic (OCT) Spinal System Ransford Cervical Fixation System (K965221) Synthes CerviFix System (K982322, K984377, K990965, K991089, K994187, K001864) When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), th…
Synthes Spine1999—
*K994187Synthes Cervifix System
Summary page 1
…Fixation Summit Occipito-Cervico-Thoracic (OCT) Spinal System Ransford Cervical Fixation System (K965221) Synthes CerviFix System (K982322, K984377, K990965, K991089, K994187, K001864) When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit…
Synthes (Usa)1999—
*K001864Synthes Cervifix System
Summary page 1
…Summit Occipito-Cervico-Thoracic (OCT) Spinal System Ransford Cervical Fixation System (K965221) Synthes CerviFix System (K982322, K984377, K990965, K991089, K994187, K001864) When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-…
Synthes Spine2000—

Also cleared against K965221: 2 other devices →

What descends from it? (671)

See all 671

16 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001660
K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002659
K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003658
K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004657
K042508Sumit Oct Spinal System and Mountaineer Oct Spinal SystemDepuy Spine, Inc.2004301
K080828Mountaineer Oct Spinal SystemDepuy Spine, Inc.2008242
K030197Blackstone Posterior Cervical SystemBlackstone Medical, Inc.2003193
K050391Protex CT Cervicothoracic Spinal SystemGlobus Medical, Inc.2005148
K101084Caspian Spinal SystemK2m, Inc.201062
K070638Theken Atoll Cervico-Thoracic SystemTheken Spine, LLC200759

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K093670Modification to: Oasys SystemStryker Spine · 2010 · 3 generations on · ◆ in the 2010 descendants bar of FIG. 11 Class I recall
  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
  • None of the 8 ancestors has a recall.
  • Of its descendants, K013222 (Depuyacromed, 2001) has gone furthest, with 660 descendants of its own.
  • 2 other devices also cite its predicate K965221.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-Cervico-Thoracic (OCT) Spinal System is indicated for: ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) spondylolisthesis spinal stenosis fracture/dislocation atlanto/axial fracture with instability occipitocervical dislocation revision of previous…

Read the full statement (121 words)

When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (occiput-T3), the Summit Occipito-Cervico-Thoracic (OCT) Spinal System is indicated for:

ddd (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies)

spondylolisthesis

spinal stenosis

fracture/dislocation

atlanto/axial fracture with instability

occipitocervical dislocation

revision of previous cervical spine surgery

tumors

The occipital bone screws are limited to occipital fixation only.

The use of the minipolyaxial screws is limited to placement 4n the tipper theracic spine (Tl-T3) in treating thoracic conditions only. They are not intended to be placed in the cervical spine.

The Songer Cable System to be used with the Summit OCT Spinal, Syst-'M allows1or wire/cable attachment to the posterior cervical spine.

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

Also cleared against K965221

2 other devices cite the same predicate.

  • K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  • K983282Omi Occipital Cervical Loop, Model A1089Ohio Medical Instrument Co., Inc. · 1998

More from Depuyacromed

48 FDA decisions under this applicant name. See the company

  • K040197Eagle Anterior Cervial Plate SystemDepuyacromed · 2004
  • K031635Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030833Depuy Acromed VBR SystemDepuyacromed · 2003
  • K030383Modification to Moss Miami Spinal System Polyaxial ScrewsDepuyacromed · 2003
  • K030249Surgical Titanium Mesh SystemDepuyacromed · 2003

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K002733 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002733: Summit Occipito-Cervico-Thoracic (Oct) Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002733

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026