510(k) · Cleared
ClearedLTD Polyaxial Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Us Spine · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Dec 26, 2006 as substantially equivalent to K980447 (DePuy Orthopaedics, Inc., 1998) and 2 other predicates after a 99-day review. Its family tree reaches back 3 generations to 2000. 41 later devices descend from it.
- Decided
- Dec 26, 2006
- Review
- 99 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K000319 (2000). 7 ancestors in all, the oldest K980447 (1998). 41 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK000319 Ebi Xfix DFS SystemEbi, L.P. · 2000
- 2 generations backK020279 Forex Corporation, Optima, Spinal SystemForex Corp. · 2002 · Recalled
- 1 generation backK031585 U&I, Optima, Spinal SystemU&I Corp., America · 2003 · Recalled
- This deviceK062785 LTD Polyaxial Fixation SystemUs Spine · 2006
- Descendant · cites it directly · 36 of its ownK062912 Scient'x Spinal SystemScient'X · 2007
- Descendant · 2 generations on · 29 of its ownK133369 Tiger Spine SystemCorelink, LLC · 2014
- Descendant · 3 generations on · 17 of its ownK153453 Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016
- Descendant · 4 generations on · 13 of its ownK192121 Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019
- Descendant · 5 generations on · 12 of its ownK213935 PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K062912Scient'x Spinal SystemScient'X · 2007 · cites it directly36descendants
- K133369Tiger Spine SystemCorelink, LLC · 2014 · 2 generations on29descendants
- K153453Inertia Pedicle Screw and Deformity Correxxion SystemNexxt Spine, LLC · 2016 · 3 generations on17descendants
- K192121Black Diamond Pedicle Screw SystemOsseus Fusion Systems · 2019 · 4 generations on13descendants
- K213935PISCES-SA Standalone ALIF Interbody SystemOsseus Fusion Systems · 2022 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K000319 | Ebi Xfix DFS System | Ebi, L.P. | 2000 | — |
| −2 | K020279 | Forex Corporation, Optima, Spinal System | Forex Corp. | 2002 | 4 |
| −1 | K031585 | U&I, Optima, Spinal System | U&I Corp., America | 2003 | 5 |
| 0 (this device) | K062785 | LTD Polyaxial Fixation System | Us Spine | 2006 | — |
| +1 | K062912 | Scient'x Spinal System | Scient'X | 2007 | — |
| +2 | K133369 | Tiger Spine System | Corelink, LLC | 2014 | — |
| +3 | K153453 | Inertia Pedicle Screw and Deformity Correxxion System | Nexxt Spine, LLC | 2016 | — |
| +4 | K192121 | Black Diamond Pedicle Screw System | Osseus Fusion Systems | 2019 | — |
| +5 | K213935 | PISCES-SA Standalone ALIF Interbody System | Osseus Fusion Systems | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 6 | 0 |
| 2024 | 6 | 0 |
| 2025 | 7 | 0 |
| 2026 | 1 | 0 |
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 KWP? 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
What was it cleared against? (3)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980447 | Depuy Motech Moss Miami Spinal SystemSummary page 1…Name: Pedicle Screw Spinal System Classification: Class 11 (888.3050, 888.3060, 888.3070) Product Codes: MNH, MNI, KWP, KWQ Predicate Devices: K980447 - Moss Miami Pedicle Fixation System K984251 - Stryker Spine Xia Spine System K0315… | 1998 |
| * | K984251 | Xia Spine SystemSummary page 1…11 (888.3050, 888.3060, 888.3070) Product Codes: MNH, MNI, KWP, KWQ Predicate Devices: K980447 - Moss Miami Pedicle Fixation System K984251 - Stryker Spine Xia Spine System K031585 - Optima Spine System Device Description: The LTD Polyaxial F… | 1999 |
| * | K031585 | U&I, Optima, Spinal SystemSummary page 1…MNI, KWP, KWQ Predicate Devices: K980447 - Moss Miami Pedicle Fixation System K984251 - Stryker Spine Xia Spine System K031585 - Optima Spine System Device Description: The LTD Polyaxial Fixation System consists of a variety of s… | 2003 |
What descends from it? (41)
See all 412 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K062912 (Scient'X, 2007) has gone furthest, with 36 descendants of its own.
- 7 other devices also cite its predicate K980447.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LTD Polyaxial Fixation System is intended to help provide immobilization and stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine, specifically as follows: When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the LTD Polyaxial Fixation system is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of…
Read the full statement (227 words)
The LTD Polyaxial Fixation System is intended to help provide immobilization and
stabilization of spinal segments as an adjunct to fusion of the lumbar and/or sacral spine,
specifically as follows:
When used as a pedicle screw fixation system of the non-cervical posterior spine in
skeletally mature patients, the LTD Polyaxial Fixation system is indicated for one or
more of the following: (1) degenerative spondylolisthesis with objective evidence of
neurologic impairment, (2) fracture, (3) dislocation, (4) spinal tumor, and/or (5) failed
previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the LTD Polyaxial Fixation
System is indicated for skeletally mature patients: (a) having severe spondylolisthesis
(Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) vertebral 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 (L3 and below); and (d) who are having the
device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the LTD
Polyaxial Fixation System is intended for the following indications: (1) degenerative disc
disease (as defined by back pain of discogenic origin with degeneration of the disc
confirmed by patient history and radiographic studies), (2) spinal stenosis, (3)
spondylolisthesis, (4) fracture, (5) pseudarthrosis, (6) tumor resection and/or (7) failed
previous fusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062785 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062785: LTD Polyaxial Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062785
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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