510(k) · Cleared
ClearedModification to Xia Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Howmedica Osteonics Corp. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Dec 5, 2001 as substantially equivalent to K982494 (Howmedica Corp., 1998) and 6 other predicates after a 28-day review. Its family tree reaches back 2 generations to 1999. 205 later devices descend from it.
- Decided
- Dec 5, 2001
- Review
- 28 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K984251 (1999). 7 ancestors in all, the oldest K951725 (1995). 205 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK984251 Xia Spine SystemHowmedica, Inc. · 1999
- 1 generation backK012027 Modification to Xia Spine SystemHowmedica Osteonics · 2001
- This deviceK013688 Modification to Xia Spinal SystemHowmedica Osteonics Corp. · 2001
- Descendant · cites it directly · 202 of its ownK052181 Modification to Xia Spinal SystemStryker Spine · 2005
- Descendant · 2 generations on · 201 of its ownK070631 Device Modification to Radius Spinal SystemStryker Spine · 2007
- Descendant · 3 generations on · 200 of its ownK082608 Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008
- Descendant · 4 generations on · 169 of its ownK091291 Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine · 2009
- Descendant · 5 generations on · 111 of its ownK120270 Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012
Showing 5 of 205 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 205 · See all- K052181Modification to Xia Spinal SystemStryker Spine · 2005 · cites it directly202descendants
- K070631Device Modification to Radius Spinal SystemStryker Spine · 2007 · 2 generations on201descendants
- K082608Radius Spinal System, Vitallium Rod #486613601Stryker Spine · 2008 · 3 generations on200descendants
- K091291Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium RodStryker Spine · 2009 · 4 generations on169descendants
- K120270Venus Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2012 · 5 generations on111descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K984251 | Xia Spine System | Howmedica, Inc. | 1999 | — |
| −1 | K012027 | Modification to Xia Spine System | Howmedica Osteonics | 2001 | — |
| 0 (this device) | K013688 | Modification to Xia Spinal System | Howmedica Osteonics Corp. | 2001 | — |
| +1 | K052181 | Modification to Xia Spinal System | Stryker Spine | 2005 | — |
| +2 | K070631 | Device Modification to Radius Spinal System | Stryker Spine | 2007 | — |
| +3 | K082608 | Radius Spinal System, Vitallium Rod #486613601 | Stryker Spine | 2008 | — |
| +4 | K091291 | Xia 3 Spinal System, Uniplanner/Reduction Screws & Vitallium Rod | Stryker Spine | 2009 | — |
| +5 | K120270 | Venus Spinal Fixation System | L&K BIOMED Co., Ltd. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 6 | 0 |
| 2015 | 9 | 0 |
| 2016 | 4 | 0 |
| 2017 | 12 | 0 |
| 2018 | 14 | 0 |
| 2019 | 11 | 0 |
| 2020 | 17 | 0 |
| 2021 | 7 | 0 |
| 2022 | 14 | 0 |
| 2023 | 26 | 0 |
| 2024 | 25 | 0 |
| 2025 | 18 | 0 |
| 2026 | 20 | 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 MNH? 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K982494 | BWM Spine SystemSummary page 1…21 CFR 888.3060 Pedicle Screw Spinal System 21 CFR 888.3070 Predicate Device Identification The Xia Spinal System was determined substantially equivalent via 510(k)s K982494, K984251, K001319, K002505 and K012027. The Xia Screws were cleared for use with the Multi-Axial Cross Connector via 510(k) K0025… | 1998 |
| * | K984251 | Xia Spine SystemSummary page 1…888.3060 Pedicle Screw Spinal System 21 CFR 888.3070 Predicate Device Identification The Xia Spinal System was determined substantially equivalent via 510(k)s K982494, K984251, K001319, K002505 and K012027. The Xia Screws were cleared for use with the Multi-Axial Cross Connector via 510(k) K002505. The R… | 1999 |
| * | K001319 | Xia Spine System HooksSummary page 1…Pedicle Screw Spinal System 21 CFR 888.3070 Predicate Device Identification The Xia Spinal System was determined substantially equivalent via 510(k)s K982494, K984251, K001319, K002505 and K012027. The Xia Screws were cleared for use with the Multi-Axial Cross Connector via 510(k) K002505. The Rods for t… | 2000 |
| * | K002505 | Xia Spine SystemSummary page 1…Screw Spinal System 21 CFR 888.3070 Predicate Device Identification The Xia Spinal System was determined substantially equivalent via 510(k)s K982494, K984251, K001319, K002505 and K012027. The Xia Screws were cleared for use with the Multi-Axial Cross Connector via 510(k) K002505. The Rods for the Osteon… | 2000 |
| * | K012027 | Modification to Xia Spine SystemSummary page 1…System 21 CFR 888.3070 Predicate Device Identification The Xia Spinal System was determined substantially equivalent via 510(k)s K982494, K984251, K001319, K002505 and K012027. The Xia Screws were cleared for use with the Multi-Axial Cross Connector via 510(k) K002505. The Rods for the Osteonics® Spinal… | 2001 |
| * | K951725 | Osteonics Spinal SystemSummary page 1…ared for use with the Multi-Axial Cross Connector via 510(k) K002505. The Rods for the Osteonics® Spinal System (OSS) were determined substantially equivalent via 510(k) K951725. The Rods for the Opus Spinal System were determined substantially equivalent via 510(k) K990922. This submission is intended to… | 1995 |
| * | K990922 | Osteonics Spinal System Versatile Cross ConnectorSummary page 1…Spinal System (OSS) were determined substantially equivalent via 510(k) K951725. The Rods for the Opus Spinal System were determined substantially equivalent via 510(k) K990922. This submission is intended to allow the use of the predicate OSS and Opus Rods with the predicate Xia Spinal System. Descripti… | 1999 |
What descends from it? (205)
See all 2052 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 2 years and passes through 3 companies; a new generation was cleared every 2.4 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K052181 (Stryker Spine, 2005) has gone furthest, with 202 descendants of its own.
- 1 other device also cites its predicate K982494.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, 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 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The XIA Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the XIA Spine System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) 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; and (d) who are having the device removed…
Read the full statement (224 words)
The XIA Spine System is intended for use in the noncervical spine. When used as a pedicle screw fixation system, the XIA Spine System is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the fifth lumbar - first sacral (L5-S1) 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; and (d) who are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw fixation system, the XIA Spine System is also intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).
When used an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the XIA Spine System is indicated for patients with degenerative disc disease which is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis or revision of failed fusion attempts.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013688: Modification to Xia 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/K013688
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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