510(k) · Cleared
ClearedOLYMPIC Deformity Band System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astura Medical · OWI Bone Fixation Cerclage, Sublaminar
Cleared on May 4, 2023 as substantially equivalent to K142053 (Zimmer Spine, Inc., 2014) and 2 other predicates after a 290-day review. Its family tree reaches back 16 generations to 2004. 3 later devices descend from it.
- Decided
- May 4, 2023
- Review
- 290 days
- Class
- Class II
- Product code
- OWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K040583 (2004). 176 ancestors in all, the oldest K781443 (1978). 3 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations between
- 3 generations backK132303 Implanet Spine SystemImplanet, S.A. · 2013
- 2 generations backK162764 Jazz Frame SystemImplanet, S.A. · 2017
- 1 generation backK170730 JAZZ System, including JAZZ BandImplanet, S.A. · 2017
- This deviceK222097 OLYMPIC Deformity Band SystemAstura Medical · 2023
- Descendant · cites it directly · 2 of its ownK231694 MASADA Modular Spinal Fixation SystemAstura Medical · 2023
- Descendant · 2 generations on · 0 of its ownK252346 OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal…Astura Medical · 2025
- Descendant · 2 generations on · 0 of its ownK243259 MASADA Modular Spinal Fixation SystemAstura Medical · 2025
Show all 16 generations
- Root · 16 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 15 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 13 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 12 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 11 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 9 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 8 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 7 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 6 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 5 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 4 generations backK120564 Calypso SystemHogan Lovells US LLP · 2012
- 3 generations backK132303 Implanet Spine SystemImplanet, S.A. · 2013
- 2 generations backK162764 Jazz Frame SystemImplanet, S.A. · 2017
- 1 generation backK170730 JAZZ System, including JAZZ BandImplanet, S.A. · 2017
- This deviceK222097 OLYMPIC Deformity Band SystemAstura Medical · 2023
Most influential descendants
Showing 3 of 3 · See all- K231694MASADA Modular Spinal Fixation SystemAstura Medical · 2023 · cites it directly2descendants
- K252346OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation SystemAstura Medical · 2025 · 2 generations on0descendants
- K243259MASADA Modular Spinal Fixation SystemAstura Medical · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −15 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −13 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −12 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −11 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −9 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −8 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −7 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −6 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −5 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −4 | K120564 | Calypso System | Hogan Lovells US LLP | 2012 | — |
| −3 | K132303 | Implanet Spine System | Implanet, S.A. | 2013 | — |
| −2 | K162764 | Jazz Frame System | Implanet, S.A. | 2017 | — |
| −1 | K170730 | JAZZ System, including JAZZ Band | Implanet, S.A. | 2017 | — |
| 0 (this device) | K222097 | OLYMPIC Deformity Band System | Astura Medical | 2023 | — |
| +1 | K231694 | MASADA Modular Spinal Fixation System | Astura Medical | 2023 | — |
| +2 | K252346 | OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System | Astura Medical | 2025 | — |
| +2 | K243259 | MASADA Modular Spinal Fixation System | Astura Medical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1984 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 6 | 0 |
| 1999 | 2 | 0 |
| 2000 | 12 | 0 |
| 2001 | 13 | 0 |
| 2002 | 11 | 0 |
| 2003 | 13 | 0 |
| 2004 | 18 | 0 |
| 2005 | 14 | 0 |
| 2006 | 11 | 0 |
| 2007 | 8 | 0 |
| 2008 | 12 | 0 |
| 2009 | 5 | 0 |
| 2010 | 4 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 2 | 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 OWI? 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 OWI device
- #1 K253615 Invictus Bands Systemscore 20.7 · 33 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K142053 | Universal Clamp Spinal Fixation SystemSummary page 5…Orthopedic Primary Predicate Zimmer Universal Clamp Spinal Fixation OLYMPIC Posterior Spinal Fixation System Device System (K142053) (K181139) Additional Predicate JAZZ System, Including JAZZ Band (K170730) Spinal USA ReF… | 2014 |
| * | K170730 | JAZZ System, including JAZZ BandSummary page 5…terior Spinal Fixation System Device System (K142053) (K181139) Additional Predicate JAZZ System, Including JAZZ Band (K170730) Spinal USA ReForm Pedicle Screw System Device(s) Medicrea International S.A. LigaPASS (K131343)… | 2017 |
| * | K173506 | LigaPASSSummary page 5…JAZZ Band (K170730) Spinal USA ReForm Pedicle Screw System Device(s) Medicrea International S.A. LigaPASS (K131343) (K173506) OLYMPIC Navigated Instruments… | 2018 |
| † | K172166 | OLYMPIC Navigated Instruments | 2018 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231694 | MASADA Modular Spinal Fixation System | 2023 | 2 |
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 19 years and passes through 6 companies; a new generation was cleared every 5 months on median.
- 22 of the 176 ancestors have a recall of any class.
- Of its descendants, K231694 (Astura Medical, 2023) has gone furthest, with 2 descendants of its own.
- 4 other devices also cite its predicate K142053.
How does its category compare?
All OWI devicesOWI Bone Fixation Cerclage, Sublaminar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OWI
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OWI
60in 2020
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWI
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWI
6in 2025
MAUDE reports naming product code OWI, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 3 | 92 | 0 | 1 |
| 2015 | 3 | 93 | 0 | 1 |
| 2016 | 5 | 98 | 0 | 6 |
| 2017 | 7 | 77 | 0 | 6 |
| 2018 | 4 | 156 | 0 | 2 |
| 2019 | 3 | 51 | 0 | 13 |
| 2020 | 3 | 60 | 1 | 8 |
| 2021 | 1 | — | 0 | 5 |
| 2022 | 1 | — | 0 | 6 |
| 2023 | 2 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications: -Spinal trauma surgery, used in sublaminar or facet wiring techniques. -Spinal reconstructive surgery, incorporated into constructs for the…
Read the full statement (377 words)
The OLYMPIC Deformity Band System is a temporary implant for use in orthopedic surgery. The band system is intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. The indications for use include the following applications:
-Spinal trauma surgery, used in sublaminar or facet wiring techniques.
-Spinal reconstructive surgery, incorporated into constructs for the purpose of correction of spinal deformities such as idiopathic and neuromuscular scoliosis in patients 8 years of age or older, adult scoliosis, kyphosis and spondylolisthesis.
-Spinal degenerative surgery, as an adjunct to spinal fusions.
The OLYMPIC Deformity Band System may also be used in conjunction with other medical grade implants made of similar metals whenever “wiring” may help secure the attachment of the other implants.
The Olympic Posterior Spinal Fixation System is intended for immobilization and stabilization of the posterior, non-cervical spine in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, curvatures (i.e., scoliosis, kyphosis, or lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Olympic Posterior Spinal Fixation System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Olympic Posterior Spinal Fixation System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The OLYMPIC NAVIGATED INSTRUMENTS are intended to be used in the preparation and placement of OLYMPIC PSFS screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are designed for use with the Medtronic StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. Refer to the Astura Navigated Instrument system Instructions For Use (INS-00006) regarding the use of these instruments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222097 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222097: OLYMPIC Deformity Band System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222097
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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