510(k) · Cleared
ClearedPOLARSTEM Calcar Reamer Guide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith & Nephew, Inc. · LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Cleared on Jul 19, 2021 as substantially equivalent to K143739 (Smith & Nephew, Inc., 2015) after a 61-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Jul 19, 2021
- Review
- 61 days
- Class
- Class II
- Product code
- LZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K932481 (1994). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK932481 SL-Plus and SLR-PlusEncore Orthopedics, Inc. · 1994
- 6 generations backK001942 SL-Plus and SLR-Plus StemsPlus Orthopedics · 2000
- 5 generations backK021178 SL-Plus Lateralized StemPlus Orthopedics · 2002
- 4 generations backK072852 SL-Plus Standard and Lateral Hip StemsSmith & Nephew, Inc. · 2008
- 3 generations backK120211 SL-Plus Standard and Lateral Femoral Stem with TI/HA CoatingSmith & Nephew, Inc. · 2012
- 2 generations backK130728 Polarstem Standard and Lateral Femoral Stems with TI/HASmith & Nephew, Inc. · 2013 · Recalled
- 1 generation backK143739 POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem…Smith & Nephew, Inc. · 2015 · Recalled
- This deviceK211548 POLARSTEM Calcar Reamer GuideSmith & Nephew, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K932481 | SL-Plus and SLR-Plus | Encore Orthopedics, Inc. | 1994 | — |
| −6 | K001942 | SL-Plus and SLR-Plus Stems | Plus Orthopedics | 2000 | — |
| −5 | K021178 | SL-Plus Lateralized Stem | Plus Orthopedics | 2002 | — |
| −4 | K072852 | SL-Plus Standard and Lateral Hip Stems | Smith & Nephew, Inc. | 2008 | — |
| −3 | K120211 | SL-Plus Standard and Lateral Femoral Stem with TI/HA Coating | Smith & Nephew, Inc. | 2012 | — |
| −2 | K130728 | Polarstem Standard and Lateral Femoral Stems with TI/HA | Smith & Nephew, Inc. | 2013 | 1 |
| −1 | K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA | Smith & Nephew, Inc. | 2015 | 1 |
| 0 (this device) | K211548 | POLARSTEM Calcar Reamer Guide | Smith & Nephew, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2005 | 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 LZO? 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 LZO device
- #1 K192827 Quadra-Pscore 19.3 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K143739 | POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HASummary page 4…de: LZO, KWY, LWJ, MEH Predicate Device: POLARSTEM™ Calcar Reamer Guide, an accessory tool included in K143739 which cleared the POLARSTEM™ Collared (Standard and Lateral) and POLARSTEM™… | 2015 |
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?
- The line of descent spans 27 years and passes through 3 companies; a new generation was cleared every 4.1 years on median.
- 3 of the 9 ancestors have a recall of any class.
- 2 other devices also cite its predicate K143739.
How does its category compare?
All LZO devicesLZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · LZO
14in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LZO
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LZO
3,244in 2025
MAUDE reports naming product code LZO, 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 | 9 | 87 | 2 | 138 |
| 2008 | 11 | 63 | 13 | 125 |
| 2009 | 7 | 83 | 42 | 189 |
| 2010 | 15 | 78 | 0 | 394 |
| 2011 | 13 | 87 | 10 | 544 |
| 2012 | 14 | 98 | 14 | 963 |
| 2013 | 26 | 100 | 0 | 1,370 |
| 2014 | 13 | 85 | 1 | 1,477 |
| 2015 | 12 | 115 | 1 | 1,348 |
| 2016 | 10 | 177 | 9 | 1,728 |
| 2017 | 16 | 257 | 5 | 2,165 |
| 2018 | 18 | 163 | 2 | 3,133 |
| 2019 | 28 | 109 | 4 | 3,066 |
| 2020 | 18 | 112 | 3 | 1,963 |
| 2021 | 12 | 170 | 0 | 2,199 |
| 2022 | 11 | 279 | 4 | 1,985 |
| 2023 | 10 | 122 | 2 | 2,066 |
| 2024 | 11 | 111 | 1 | 2,586 |
| 2025 | 14 | 119 | 1 | 3,244 |
| 2026 | 9 | 102 | 0 | — |
What is it indicated for?
The POLARSTEM™ femoral stems with Ti/HA are indicated for:
• Advanced degeneration of the hip joint as a result of degenerative, post-traumatic or rheumatoid arthritis.
• Fracture or avascular necrosis of the femoral head.
• Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
The POLARSTEM™ with Ti/HA is intended for single use only and is to be implanted without bone cement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211548 · printed Nov 6, 2026
Cite this page
510(k) Report. “K211548: POLARSTEM Calcar Reamer Guide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K211548
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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